Trial Outcomes & Findings for Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA) (NCT NCT02093026)
NCT ID: NCT02093026
Last Updated: 2017-03-13
Results Overview
A participant had an ACR20 response if there was at least a 20 percent (%) improvement, ie, reduction from Baseline, in tender joint count (TJC) and swollen joint count (SJC) (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[visual analog scale (VAS): 0=no disease activity to 100=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0=no disease activity to 100=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0=no pain to 100=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either C-reactive protein \[CRP\] or erythrocyte sedimentation rate \[ESR\]). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
465 participants
Primary outcome timeframe
24 weeks after first course of rituximab (up to approximately 26 weeks)
Results posted on
2017-03-13
Participant Flow
This study included participants who had previously participated in studies WA16291 (NCT02693210) or WA17043 (NCT00074438).
Participant milestones
| Measure |
Rituximab
Participants received rituximab 1 gram intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 milligrams per week (mg/week) orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid greater than or equal to (\>=) 5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
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Overall Study
STARTED
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465
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Overall Study
COMPLETED
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272
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Overall Study
NOT COMPLETED
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193
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Reasons for withdrawal
| Measure |
Rituximab
Participants received rituximab 1 gram intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 milligrams per week (mg/week) orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid greater than or equal to (\>=) 5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
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Overall Study
Adverse Event
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26
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Overall Study
Death
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10
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Overall Study
Other
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157
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Baseline Characteristics
Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA)
Baseline characteristics by cohort
| Measure |
Rituximab
n=465 Participants
Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid \>=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
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Age, Continuous
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51 years
STANDARD_DEVIATION 12.01 • n=5 Participants
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Sex: Female, Male
Female
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364 Participants
n=5 Participants
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Sex: Female, Male
Male
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101 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 24 weeks after first course of rituximab (up to approximately 26 weeks)Population: Intent to treat (ITT) Population included all participants who received any part of an infusion of study medication under Study WA16855. Here, number of participants analyzed = participants who were evaluable for this outcome.
A participant had an ACR20 response if there was at least a 20 percent (%) improvement, ie, reduction from Baseline, in tender joint count (TJC) and swollen joint count (SJC) (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[visual analog scale (VAS): 0=no disease activity to 100=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0=no disease activity to 100=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0=no pain to 100=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either C-reactive protein \[CRP\] or erythrocyte sedimentation rate \[ESR\]). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.
Outcome measures
| Measure |
Rituximab
n=447 Participants
Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid \>=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
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Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response After First Course
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67.1 percentage of participants
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PRIMARY outcome
Timeframe: 24 weeks after second course of rituximab (median duration of 90.9 weeks)Population: ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome.
A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[VAS: 0=no disease activity to 100=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0=no disease activity to 100=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0=no pain to 100=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.
Outcome measures
| Measure |
Rituximab
n=384 Participants
Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid \>=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
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Percentage of Participants With ACR20 Response After Second Course
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70.8 percentage of participants
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PRIMARY outcome
Timeframe: 24 weeks after third course of rituximab (median duration of 162.9 weeks)Population: ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome.
A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[VAS: 0=no disease activity to 100=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0=no disease activity to 100=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0=no pain to 100=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.
Outcome measures
| Measure |
Rituximab
n=310 Participants
Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid \>=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
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Percentage of Participants With ACR20 Response After Third Course
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73.2 percentage of participants
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PRIMARY outcome
Timeframe: 24 weeks after fourth course of rituximab (median duration of 232 weeks)Population: ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome.
A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[VAS: 0=no disease activity to 100=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0=no disease activity to 100=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0=no pain to 100=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.
Outcome measures
| Measure |
Rituximab
n=245 Participants
Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid \>=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
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Percentage of Participants With ACR20 Response After Fourth Course
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75.1 percentage of participants
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PRIMARY outcome
Timeframe: 24 weeks after fifth course of rituximab (median duration of 297.3 weeks)Population: ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome.
A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[VAS: 0=no disease activity to 100=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0=no disease activity to 100=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0=no pain to 100=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.
Outcome measures
| Measure |
Rituximab
n=175 Participants
Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid \>=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
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Percentage of Participants With ACR20 Response After Fifth Course
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69.7 percentage of participants
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PRIMARY outcome
Timeframe: 24 weeks after sixth course of rituximab (median duration of 354.4 weeks)Population: ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome.
A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[VAS: 0=no disease activity to 100=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0=no disease activity to 100=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0=no pain to 100=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.
Outcome measures
| Measure |
Rituximab
n=110 Participants
Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid \>=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
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Percentage of Participants With ACR20 Response After Sixth Course
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68.2 percentage of participants
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PRIMARY outcome
Timeframe: 24 weeks after seventh course of rituximab (median duration of 406.7 weeks)Population: ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome.
A participant had an ACR20 response if there was at least a 20% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity \[VAS: 0=no disease activity to 100=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0=no disease activity to 100=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0=no pain to 100=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (either CRP or ESR). The ACR20 response was compared to Baseline in the precursor studies WA16291 or WA17043.
Outcome measures
| Measure |
Rituximab
n=74 Participants
Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid \>=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
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Percentage of Participants With ACR20 Response After Seventh Course
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59.5 percentage of participants
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SECONDARY outcome
Timeframe: 24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)Population: ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome. Number analyzed = participants who were evaluable for specified category.
A participant had an ACR50 and ACR70 response if there was at least a 50% or 70% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of disease activity \[VAS: 0=no disease activity to 100=maximum disease activity\]; 2) Patient's Global Assessment of Disease Activity \[VAS: 0=no disease activity to 100=maximum disease activity\]; 3) Patient's Assessment of Pain \[VAS: 0=no pain to 100=unbearable pain\]; 4) Health Assessment Questionnaire \[20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do\] and 5) an acute-phase reactant (CRP or ESR). The ACR50 and ACR70 responses were compared to Baseline in the precursor studies WA16291 or WA17043.
Outcome measures
| Measure |
Rituximab
n=447 Participants
Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid \>=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
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Percentage of Participants With ACR50 and ACR70 Response
ACR50: 24 weeks after first course
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39.4 percentage of participants
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Percentage of Participants With ACR50 and ACR70 Response
ACR50: 24 weeks after second course
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41.9 percentage of participants
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Percentage of Participants With ACR50 and ACR70 Response
ACR50: 24 weeks after third course
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44.8 percentage of participants
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Percentage of Participants With ACR50 and ACR70 Response
ACR50: 24 weeks after fourth course
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46.9 percentage of participants
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Percentage of Participants With ACR50 and ACR70 Response
ACR50: 24 weeks after fifth course
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40.0 percentage of participants
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Percentage of Participants With ACR50 and ACR70 Response
ACR50: 24 weeks after sixth course
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40.0 percentage of participants
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Percentage of Participants With ACR50 and ACR70 Response
ACR50: 24 weeks after seventh course
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36.5 percentage of participants
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Percentage of Participants With ACR50 and ACR70 Response
ACR70: 24 weeks after first course
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16.3 percentage of participants
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Percentage of Participants With ACR50 and ACR70 Response
ACR70: 24 weeks after second course
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21.6 percentage of participants
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Percentage of Participants With ACR50 and ACR70 Response
ACR70: 24 weeks after third course
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20.0 percentage of participants
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Percentage of Participants With ACR50 and ACR70 Response
ACR70: 24 weeks after fourth course
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20.0 percentage of participants
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Percentage of Participants With ACR50 and ACR70 Response
ACR70: 24 weeks after fifth course
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18.9 percentage of participants
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Percentage of Participants With ACR50 and ACR70 Response
ACR70: 24 weeks after sixth course
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20.9 percentage of participants
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Percentage of Participants With ACR50 and ACR70 Response
ACR70: 24 weeks after seventh course
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18.9 percentage of participants
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SECONDARY outcome
Timeframe: 24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)Population: ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome. Number analyzed = participants who were evaluable for specified category.
The ACRn is calculated for each participant by taking the lowest percentage improvement in (1) SJC or (2) TJC or (3) the median of the remaining 5 components of the ACR response (patient's assessment of disease activity; patient's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value \[either CRP or ESR\]). The index of improvement in RA, where 0 indicates no improvement and 100 indicates a 100% improvement across all signs and symptoms of RA. ACRn scores were calculated considering the original baseline in the precursor studies WA16291 or WA17043.
Outcome measures
| Measure |
Rituximab
n=447 Participants
Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid \>=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
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American College of Rheumatology Index of Improvement (ACRn) Response
24 weeks after first course
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31.07 units on a scale
Standard Deviation 50.188
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American College of Rheumatology Index of Improvement (ACRn) Response
24 weeks after second course
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34.15 units on a scale
Standard Deviation 58.769
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American College of Rheumatology Index of Improvement (ACRn) Response
24 weeks after third course
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36.93 units on a scale
Standard Deviation 44.912
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American College of Rheumatology Index of Improvement (ACRn) Response
24 weeks after fourth course
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39.59 units on a scale
Standard Deviation 39.393
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American College of Rheumatology Index of Improvement (ACRn) Response
24 weeks after fifth course
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33.76 units on a scale
Standard Deviation 48.309
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American College of Rheumatology Index of Improvement (ACRn) Response
24 weeks after sixth course
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29.74 units on a scale
Standard Deviation 57.197
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American College of Rheumatology Index of Improvement (ACRn) Response
24 weeks after seventh course
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24.87 units on a scale
Standard Deviation 51.336
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SECONDARY outcome
Timeframe: 24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)Population: ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome. Number analyzed = participants who were evaluable for specified category.
DAS28-ESR was calculated from SJC and TJC using 28 joints count, ESR (millimeters per hour \[mm/hour\]), and Patient's Global Assessment of Disease Activity (VAS: 0=no disease activity to 100=maximum disease activity). DAS28-ESR = 0.56\*square root (sqrt)(TJC28) + 0.28\*sqrt(SJC28) + 0.70\*natural logarithm (ln) (ESR) + 0.014\*Patient's Global Assessment of Disease Activity. Total score range: 0-10, higher score=more disease activity. DAS28-ESR \<= 3.2 implied low disease activity (LDA) and DAS28-ESR \<2.6 = clinical remission.
Outcome measures
| Measure |
Rituximab
n=441 Participants
Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid \>=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
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Percentage of Participants With Low Disease Activity and Clinical Remission Based on DAS28-ESR
LDA: 24 weeks after first course
|
24.3 percentage of participants
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Percentage of Participants With Low Disease Activity and Clinical Remission Based on DAS28-ESR
LDA: 24 weeks after second course
|
30.1 percentage of participants
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Percentage of Participants With Low Disease Activity and Clinical Remission Based on DAS28-ESR
LDA: 24 weeks after third course
|
29.3 percentage of participants
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Percentage of Participants With Low Disease Activity and Clinical Remission Based on DAS28-ESR
LDA: 24 weeks after fourth course
|
28.0 percentage of participants
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Percentage of Participants With Low Disease Activity and Clinical Remission Based on DAS28-ESR
LDA: 24 weeks after fifth course
|
23.8 percentage of participants
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Percentage of Participants With Low Disease Activity and Clinical Remission Based on DAS28-ESR
LDA: 24 weeks after sixth course
|
27.3 percentage of participants
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Percentage of Participants With Low Disease Activity and Clinical Remission Based on DAS28-ESR
LDA: 24 weeks after seventh course
|
24.7 percentage of participants
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Percentage of Participants With Low Disease Activity and Clinical Remission Based on DAS28-ESR
Remission: 24 weeks after first course
|
11.3 percentage of participants
|
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Percentage of Participants With Low Disease Activity and Clinical Remission Based on DAS28-ESR
Remission: 24 weeks after third course
|
17.1 percentage of participants
|
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Percentage of Participants With Low Disease Activity and Clinical Remission Based on DAS28-ESR
Remission: 24 weeks after fourth course
|
15.7 percentage of participants
|
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Percentage of Participants With Low Disease Activity and Clinical Remission Based on DAS28-ESR
Remission: 24 weeks after fifth course
|
15.7 percentage of participants
|
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Percentage of Participants With Low Disease Activity and Clinical Remission Based on DAS28-ESR
Remission: 24 weeks after sixth course
|
17.3 percentage of participants
|
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Percentage of Participants With Low Disease Activity and Clinical Remission Based on DAS28-ESR
Remission: 24 weeks after seventh course
|
13.7 percentage of participants
|
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Percentage of Participants With Low Disease Activity and Clinical Remission Based on DAS28-ESR
Remission: 24 weeks after second course
|
16.8 percentage of participants
|
SECONDARY outcome
Timeframe: 24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)Population: ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome. Number analyzed = participants who were evaluable for specified category.
DAS28-ESR was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and Physician's Global Assessment of Disease Activity (VAS: 0=no disease activity to 100=maximum disease activity). DAS28-ESR = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.70\*ln(ESR) + 0.014\*Patient's Global Assessment of Disease Activity. The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders had a change from baseline greater than (\>) 1.2 with a DAS28 score less than or equal to (≤) 3.2; moderate responders had a change from baseline \>1.2 with a DAS28 score \>3.2 to less than or equal to (≤) 5.1 or a change from baseline \>0.6 to ≤1.2 with a DAS28 score ≤5.1.
Outcome measures
| Measure |
Rituximab
n=436 Participants
Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid \>=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
|
|---|---|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate'
Moderate: 24 weeks after first course
|
57.8 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate'
Moderate: 24 weeks after second course
|
58.5 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate'
Moderate: 24 weeks after third course
|
59.5 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate'
Moderate: 24 weeks after fourth course
|
60.9 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate'
Moderate: 24 weeks after fifth course
|
62.1 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate'
Moderate: 24 weeks after sixth course
|
57.0 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate'
Moderate: 24 weeks after seventh course
|
60.0 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate'
Good: 24 weeks after first course
|
24.3 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate'
Good: 24 weeks after second course
|
30.4 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate'
Good: 24 weeks after third course
|
29.1 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate'
Good: 24 weeks after fourth course
|
27.9 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate'
Good: 24 weeks after fifth course
|
24.3 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate'
Good: 24 weeks after sixth course
|
27.1 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate'
Good: 24 weeks after seventh course
|
25.7 percentage of participants
|
SECONDARY outcome
Timeframe: 24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)Population: ITT Population. Here, number of participants analyzed = participants who were evaluable for this outcome. Number analyzed = participants who were evaluable for specified category.
The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Participants completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.
Outcome measures
| Measure |
Rituximab
n=447 Participants
Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid \>=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
|
|---|---|
|
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at 24 Weeks Following Each Course
24 weeks after first course
|
-0.51 units on a scale
Standard Deviation 0.555
|
|
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at 24 Weeks Following Each Course
24 weeks after second course
|
-0.48 units on a scale
Standard Deviation 0.556
|
|
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at 24 Weeks Following Each Course
24 weeks after third course
|
-0.43 units on a scale
Standard Deviation 0.532
|
|
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at 24 Weeks Following Each Course
24 weeks after fourth course
|
-0.47 units on a scale
Standard Deviation 0.529
|
|
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at 24 Weeks Following Each Course
24 weeks after fifth course
|
-0.44 units on a scale
Standard Deviation 0.541
|
|
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at 24 Weeks Following Each Course
24 weeks after sixth course
|
-0.38 units on a scale
Standard Deviation 0.600
|
|
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at 24 Weeks Following Each Course
24 weeks after seventh course
|
-0.37 units on a scale
Standard Deviation 0.576
|
SECONDARY outcome
Timeframe: 24 weeks after first, second, third, fourth, fifth, sixth, and seventh course of rituximab (median duration of 26, 90.9, 162.9, 232, 297.3, 354.4, and 406.7 weeks, respectively)Population: The data for this outcome measure was not analyzed as this outcome was removed per changes in the planned analysis. Per changes in the planned analysis, only key efficacy parameters were analyzed as the long-term efficacy of rituximab is well established.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First, second, third, fourth, fifth, sixth, and seventh course of rituximab (up to a median of approximately 2, 62, 124, 186, 248, 310, and 372 weeks, respectively)Population: Safety Population. Number analyzed = participants who were evaluable for specified category.
Outcome measures
| Measure |
Rituximab
n=465 Participants
Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid \>=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
|
|---|---|
|
Percentage of Participants Who Discontinued Treatment Due to Insufficient Response
First course
|
1.1 percentage of participants
|
|
Percentage of Participants Who Discontinued Treatment Due to Insufficient Response
Second course
|
2.3 percentage of participants
|
|
Percentage of Participants Who Discontinued Treatment Due to Insufficient Response
Third course
|
2.0 percentage of participants
|
|
Percentage of Participants Who Discontinued Treatment Due to Insufficient Response
Fourth course
|
2.0 percentage of participants
|
|
Percentage of Participants Who Discontinued Treatment Due to Insufficient Response
Fifth course
|
0.8 percentage of participants
|
|
Percentage of Participants Who Discontinued Treatment Due to Insufficient Response
Sixth course
|
0.0 percentage of participants
|
|
Percentage of Participants Who Discontinued Treatment Due to Insufficient Response
Seventh course
|
0.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to 10 yearsPopulation: ITT Population. Here, number of participants analyzed = participants who entered into safety follow-up.
Time since last treatment course = The last day of the last dose of rituximab to date of last contact. Date of last contact is the last available date of efficacy, complete medication start date, laboratory, adverse event assessments, early withdrawal visit, date of last contact, or date of death.
Outcome measures
| Measure |
Rituximab
n=31 Participants
Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid \>=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
|
|---|---|
|
Time Since Last Treatment Course
|
4.21 years
Standard Deviation 2.234
|
Adverse Events
Rituximab
Serious events: 230 serious events
Other events: 422 other events
Deaths: 0 deaths
Placebo
Serious events: 12 serious events
Other events: 93 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rituximab
n=465 participants at risk
Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid \>=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
|
Placebo
n=127 participants at risk
Data for participants who received placebo in Study WA17043 or WA16291 are included in this reporting group for data collected until they received their first dose of rituximab in this study (Study WA16855). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal oncocytoma
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland adenoma
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Pneumonia
|
2.8%
13/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.79%
1/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Urinary tract infection
|
1.5%
7/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.3%
6/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Cellulitis
|
1.1%
5/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Bronchopneumonia
|
0.86%
4/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Gastroenteritis
|
0.86%
4/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Respiratory tract infection
|
0.65%
3/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.79%
1/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Bronchitis
|
0.65%
3/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Urosepsis
|
0.65%
3/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Appendicitis
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Arthritis bacterial
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Diverticulitis
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Herpes simplex
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Pyelonephritis
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Pyelonephritis acute
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Septic shock
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Abscess bacterial
|
0.00%
0/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.79%
1/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Appendicitis perforated
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Arthritis infective
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Atypical pneumonia
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Bursitis infective
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Clostridium difficile infection
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Clostridium difficile sepsis
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Empyema
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Epiglottitis
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Gastroenteritis escherichia coli
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Herpes zoster
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Infection
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Kidney infection
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Laryngitis
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Lobar pneumonia
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Localised infection
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Otitis media
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Pharyngitis
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Postopeative wound infection
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Sepsis
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Sinusitis
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Staphylococcal skin infection
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Urinary tract infection styphlococcal
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
4.1%
19/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.79%
1/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.6%
12/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Joint destruction
|
1.3%
6/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.65%
3/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.65%
3/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.65%
3/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.79%
1/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Connective tissue disorder
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degenration
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Still's disease adult onset
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Injury, poisoning and procedural complications
Fall
|
4.1%
19/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.86%
4/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Injury, poisoning and procedural complications
Accident
|
0.65%
3/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.65%
3/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.65%
3/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Injury, poisoning and procedural complications
Femure fracture
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Injury, poisoning and procedural complications
Gastroenteritis radiation
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.79%
1/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Injury, poisoning and procedural complications
Wound
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Cardiac disorders
Myocardial infarction
|
1.9%
9/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Cardiac disorders
Coronary artery disease
|
1.1%
5/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.86%
4/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Cardiac disorders
Atrial fibrillation
|
0.65%
3/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.65%
3/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Cardiac disorders
Angina pectoris
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Cardiac disorders
Cardiac arrest
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Cardiac disorders
Pericarditis
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Cardiac disorders
Acute myocardial infaction
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Cardiac disorders
Angina unstable
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Cardiac disorders
Arrhythmia
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Cardiac disorders
Atrial flutter
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Cardiac disorders
Cardiac failure
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Cardiac disorders
Heart valve incompetence
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Cardiac disorders
Myocarditis
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.86%
4/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostrate cancer
|
0.65%
3/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.79%
1/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer stage I
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phaeochromocytoma
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.86%
4/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.65%
3/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Respiratory, thoracic and mediastinal disorders
Rheumatoid lung
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
General disorders
Device dislocation
|
1.3%
6/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
General disorders
Chest pain
|
0.86%
4/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
General disorders
Infusion related reaction
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.79%
1/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
General disorders
Death
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
General disorders
Device failure
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
General disorders
Drug interaction
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
General disorders
Pyrexia
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Gastrointestinal disorders
Constipation
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Gastrointestinal disorders
Gastritis
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Gastrointestinal disorders
Ileus
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Gastrointestinal disorders
Melaena
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Gastrointestinal disorders
Umbilical hernia obstructive
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Gastrointestinal disorders
Vomiting
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Nervous system disorders
Syncope
|
0.86%
4/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Nervous system disorders
Headache
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Nervous system disorders
Cerebral circulatory failure
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Nervous system disorders
Cerebral infarction
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Nervous system disorders
Cervical myelopathy
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Nervous system disorders
Ischaemic stroke
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Nervous system disorders
Presyncope
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Nervous system disorders
Serotonin syndrome
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Vascular disorders
Deep vein thrombosis
|
0.65%
3/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Vascular disorders
Venous thrombosis limb
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Vascular disorders
Angiopathy
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Vascular disorders
Aortic stenosis
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Vascular disorders
Hypertension
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Vascular disorders
Rheumatoid vasculitis
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Vascular disorders
Thromboangiitis obliterans
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Vascular disorders
Vasculitis
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.65%
3/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Reproductive system and breast disorders
Cystocele
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Reproductive system and breast disorders
Ovulation pain
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Reproductive system and breast disorders
Uterine cervical erosion
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.65%
3/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.79%
1/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Hepatobiliary disorders
Biliary colic
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Hepatobiliary disorders
Fatty liver alcoholic
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.65%
3/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Blood and lymphatic system disorders
Anaemia megaloblastic
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.86%
4/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.79%
1/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.65%
3/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Renal and urinary disorders
Bladder disorder
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Renal and urinary disorders
Renal failure acute
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Renal and urinary disorders
Renal impairment
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Renal and urinary disorders
Stag horn calculus
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Renal and urinary disorders
Urethral caruncle
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Psychiatric disorders
Psychotic disorder
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Psychiatric disorders
Suicidal ideation
|
0.43%
2/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Psychiatric disorders
Anxiety
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Psychiatric disorders
Depression
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Psychiatric disorders
Suicide attempt
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Congenital, familial and genetic disorders
Cerebrovascular arteriovenous malformation
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Congenital, familial and genetic disorders
Mesonephric duct cyst
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Ear and labyrinth disorders
Vertigo
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Endocrine disorders
Basedow's disease
|
0.00%
0/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.79%
1/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Endocrine disorders
Goitre
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Surgical and medical procedures
Abortion induced
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Surgical and medical procedures
Limb operation
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Eye disorders
Cataract
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Immune system disorders
Drug hypersensitivity
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Investigations
Weight decreased
|
0.00%
0/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.79%
1/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.22%
1/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
Other adverse events
| Measure |
Rituximab
n=465 participants at risk
Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid \>=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment was based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
|
Placebo
n=127 participants at risk
Data for participants who received placebo in Study WA17043 or WA16291 are included in this reporting group for data collected until they received their first dose of rituximab in this study (Study WA16855). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
32.9%
153/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
5.5%
7/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Nasopharyngitis
|
31.2%
145/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
10.2%
13/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Bronchitis
|
23.2%
108/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
4.7%
6/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Urinary tract infection
|
21.9%
102/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
7.1%
9/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Influenza
|
12.0%
56/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
2.4%
3/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Sinusitis
|
11.0%
51/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.79%
1/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Pharyngitis
|
7.3%
34/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
3.9%
5/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Gastroenteritis
|
6.7%
31/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.79%
1/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Lower respiratory tract infection
|
6.0%
28/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
1.6%
2/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Infections and infestations
Herpes zoster
|
5.6%
26/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.79%
1/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
50.8%
236/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
42.5%
54/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.1%
84/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
5.5%
7/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
58/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
2.4%
3/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
8.6%
40/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.79%
1/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.9%
32/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.79%
1/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
6.2%
29/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.79%
1/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
5.8%
27/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
2.4%
3/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
26/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
General disorders
Infusion related reaction
|
43.7%
203/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
19.7%
25/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
General disorders
Oedema peripheral
|
9.7%
45/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
5.5%
7/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
General disorders
Fatigue
|
8.2%
38/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
6.3%
8/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.3%
85/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
7.1%
9/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
62/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
6.3%
8/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.6%
54/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
1.6%
2/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Gastrointestinal disorders
Abdominal pain uppper
|
6.0%
28/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
1.6%
2/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
26/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
1.6%
2/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
25/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
2.4%
3/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Nervous system disorders
Headache
|
17.6%
82/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
7.1%
9/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Nervous system disorders
Dizziness
|
6.9%
32/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
1.6%
2/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Vascular disorders
Hypertension
|
20.0%
93/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
4.7%
6/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Psychiatric disorders
Depression
|
8.8%
41/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Psychiatric disorders
Insomnia
|
6.2%
29/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
2.4%
3/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Injury, poisoning and procedural complications
Fall
|
13.8%
64/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.5%
49/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
3.9%
5/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.2%
43/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
3.1%
4/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
8.0%
37/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
2.4%
3/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Blood and lymphatic system disorders
Anaemia
|
8.4%
39/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Eye disorders
Cataract
|
6.2%
29/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.00%
0/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
|
Ear and labyrinth disorders
Vertigo
|
5.8%
27/465 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
0.79%
1/127 • Baseline up to approximately 11 years
The rituximab treatment group includes all data beginning with the first treatment with rituximab (either in Study WA17043 or Study WA16291 or Study WA16855). Participants who received placebo are included in the rituximab treatment group from the time they received their first course of rituximab.
|
Additional Information
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