Trial Outcomes & Findings for A Study Comparing Maintenance Subcutaneous Rituximab With Observation Only in Participants With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma Who Had Responded to Rituximab-based Immunochemotherapy Induction and 2-year Maintenance With Subcutaneous Rituximab (NCT NCT01461928)

NCT ID: NCT01461928

Last Updated: 2019-08-06

Results Overview

Progression free survival from randomization (PFSrand) is defined as the time from date of randomization to the date of first documented disease progression or death, whichever occurs first. One participant died in Induction before randomization and one participant died in Maintenance II Observation arm due to an SAE and were not considered in the analysis as no death page was completed. The Observation arm did not include one participant with AE outcome of death reported retrospectively 2 months after discontinuation from study (censored as having no event on Day 456 post-randomization).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

692 participants

Primary outcome timeframe

From randomization (Maintenance II) up to disease progression or death, whichever occurs first (up to approximately 24 months)

Results posted on

2019-08-06

Participant Flow

Participants were identified for potential recruitment using pre-screening enrolment logs.

Participants were treated with an induction regimen (6 months) and received SC rituximab at a dose of 375 mg/m2 with chemotherapy followed by 2 years of Maintenance I SC rituximab of 1400 mg alone. Responding participants at the end of Maintenance I were randomized to either Maintenance II rituximab treatment or observation only.

Participant milestones

Participant milestones
Measure
All Participants
Participants were enrolled in an Induction period (up to 8 months) and received SC rituximab at a dose of 375 mg/m2 body surface area (BSA) followed by standard chemotherapy then continued into Maintenance I period (up to 24 months) and received SC rituximab of 1400 mg without chemotherapy. Participants who completed the Induction and Maintenance I periods with SC rituximab and for whom Partial Response (PR) or Complete Response (CR) was confirmed, were considered responders and were then randomized to receive either prolonged SC rituximab continued until disease progression or until the end of study (Maintenance II; Rituximab arm) or observation with no further treatment until the end of study (Maintenance II; Observation arm).
Maintenance II - Arm A (Rituximab)
Participants were randomized to receive SC rituximab administered as a single injection of 1400 mg fixed dose without chemotherapy every 8 weeks until disease progression or until the end of study.
Maintenance II - Arm B (Observation Only)
Participants were randomized to no longer receive SC rituximab but observed until the end of study.
Induction (up to 8 Months)
STARTED
692
0
0
Induction (up to 8 Months)
COMPLETED
494
0
0
Induction (up to 8 Months)
NOT COMPLETED
198
0
0
Maintenance I (24 Months)
STARTED
494
0
0
Maintenance I (24 Months)
COMPLETED
276
0
0
Maintenance I (24 Months)
NOT COMPLETED
218
0
0
Maintenance II (15 Months)
STARTED
0
138
138
Maintenance II (15 Months)
COMPLETED
0
115
111
Maintenance II (15 Months)
NOT COMPLETED
0
23
27

Reasons for withdrawal

Reasons for withdrawal
Measure
All Participants
Participants were enrolled in an Induction period (up to 8 months) and received SC rituximab at a dose of 375 mg/m2 body surface area (BSA) followed by standard chemotherapy then continued into Maintenance I period (up to 24 months) and received SC rituximab of 1400 mg without chemotherapy. Participants who completed the Induction and Maintenance I periods with SC rituximab and for whom Partial Response (PR) or Complete Response (CR) was confirmed, were considered responders and were then randomized to receive either prolonged SC rituximab continued until disease progression or until the end of study (Maintenance II; Rituximab arm) or observation with no further treatment until the end of study (Maintenance II; Observation arm).
Maintenance II - Arm A (Rituximab)
Participants were randomized to receive SC rituximab administered as a single injection of 1400 mg fixed dose without chemotherapy every 8 weeks until disease progression or until the end of study.
Maintenance II - Arm B (Observation Only)
Participants were randomized to no longer receive SC rituximab but observed until the end of study.
Induction (up to 8 Months)
Adverse Event
76
0
0
Induction (up to 8 Months)
Death
3
0
0
Induction (up to 8 Months)
Lost to Follow-up
5
0
0
Induction (up to 8 Months)
Physician Decision
9
0
0
Induction (up to 8 Months)
Withdrawal by Subject
18
0
0
Induction (up to 8 Months)
Disease progression
45
0
0
Induction (up to 8 Months)
Eligibility criteria deviation
10
0
0
Induction (up to 8 Months)
Completed Induction, no Maint I received
11
0
0
Induction (up to 8 Months)
Not responding to treatment
11
0
0
Induction (up to 8 Months)
Termination of study in Switzerland
1
0
0
Induction (up to 8 Months)
Treated before eligibility was confirmed
1
0
0
Induction (up to 8 Months)
Sponsor decision
1
0
0
Induction (up to 8 Months)
Protocol deviation
2
0
0
Induction (up to 8 Months)
Prednisolone given prior to enrolment
1
0
0
Induction (up to 8 Months)
Cycle 7 rituximab not given in error
1
0
0
Induction (up to 8 Months)
Promotor request
1
0
0
Induction (up to 8 Months)
Exceeded time limit for next cycle
1
0
0
Induction (up to 8 Months)
Medical advisor request
1
0
0
Maintenance I (24 Months)
Death
3
0
0
Maintenance I (24 Months)
Withdrawal by Subject
32
0
0
Maintenance I (24 Months)
Lost to Follow-up
2
0
0
Maintenance I (24 Months)
Diseases progression
91
0
0
Maintenance I (24 Months)
Adverse Event
70
0
0
Maintenance I (24 Months)
Physician Decision
9
0
0
Maintenance I (24 Months)
Did not meet randomization criteria
2
0
0
Maintenance I (24 Months)
Did not perform scheduled assessment
2
0
0
Maintenance I (24 Months)
Delay in rituximab administration
1
0
0
Maintenance I (24 Months)
Not compliant
1
0
0
Maintenance I (24 Months)
Did not meet criteria
5
0
0
Maintenance II (15 Months)
Adverse Event
0
2
0
Maintenance II (15 Months)
Death
0
10
8
Maintenance II (15 Months)
Physician Decision
0
0
4
Maintenance II (15 Months)
Lost to Follow-up
0
1
0
Maintenance II (15 Months)
Moved to another town
0
1
0
Maintenance II (15 Months)
Disease progression
0
0
3
Maintenance II (15 Months)
Withdrawal by Subject
0
9
8
Maintenance II (15 Months)
Changed physician in another hospital
0
0
1
Maintenance II (15 Months)
Squamous lung carcinoma
0
0
1
Maintenance II (15 Months)
Withdrew informed consent
0
0
1
Maintenance II (15 Months)
Refused to be transferred to other site
0
0
1

Baseline Characteristics

A Study Comparing Maintenance Subcutaneous Rituximab With Observation Only in Participants With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma Who Had Responded to Rituximab-based Immunochemotherapy Induction and 2-year Maintenance With Subcutaneous Rituximab

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Participants
n=692 Participants
Participants were enrolled in an Induction period (up to 8 months) and received SC rituximab at a dose of 375 mg/m2 body surface area (BSA) followed by standard chemotherapy then continued into Maintenance I period (up to 24 months) and received SC rituximab of 1400 mg without chemotherapy. Participants who completed the Induction and Maintenance I periods with SC rituximab and for whom Partial Response (PR) or Complete Response (CR) was confirmed, were considered responders and were then randomized to receive either prolonged SC rituximab continued until disease progression or until the end of study (Maintenance II; Rituximab arm) or observation with no further treatment until the end of study (Maintenance II; Observation arm).
Age, Continuous
64.6 years
STANDARD_DEVIATION 11.14 • n=5 Participants
Sex: Female, Male
Female
346 Participants
n=5 Participants
Sex: Female, Male
Male
346 Participants
n=5 Participants
Race/Ethnicity, Customized
Caucasian
579 Participants
n=5 Participants
Race/Ethnicity, Customized
Black
7 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
5 Participants
n=5 Participants
Race/Ethnicity, Customized
Other
32 Participants
n=5 Participants
Race/Ethnicity, Customized
Not applicable as per local regulation
69 Participants
n=5 Participants

PRIMARY outcome

Timeframe: From randomization (Maintenance II) up to disease progression or death, whichever occurs first (up to approximately 24 months)

Population: The primary efficacy analysis population was the ITT population (ITTrand), which included only randomised participants (Maintenance II only) and was used for the analysis of the primary efficacy endpoint of PFS and the secondary analysis endpoint overall survival (OS). The PFS end point was not reached.

Progression free survival from randomization (PFSrand) is defined as the time from date of randomization to the date of first documented disease progression or death, whichever occurs first. One participant died in Induction before randomization and one participant died in Maintenance II Observation arm due to an SAE and were not considered in the analysis as no death page was completed. The Observation arm did not include one participant with AE outcome of death reported retrospectively 2 months after discontinuation from study (censored as having no event on Day 456 post-randomization).

Outcome measures

Outcome measures
Measure
Maintenance II - Arm A (Rituximab)
n=138 Participants
Participants were randomized to receive SC rituximab administered as a single injection of 1400 mg fixed dose without chemotherapy every 8 weeks until disease progression or until the end of study.
Maintenance II - Arm B (Observation Only)
n=138 Participants
Participants were randomized to no longer receive SC rituximab but observed until the end of study.
All Participants
Participants were enrolled in an Induction period (up to 8 months) and received SC rituximab at a dose of 375 mg/m2 body surface area (BSA) followed by standard chemotherapy then continued into Maintenance I period (up to 24 months) and received SC rituximab of 1400 mg without chemotherapy. Participants who completed the Induction and Maintenance I periods with SC rituximab and for whom Partial Response (PR) or Complete Response (CR) was confirmed, were considered responders and were then randomized to receive either prolonged SC rituximab continued until disease progression or until the end of study (Maintenance II; Rituximab arm) or observation with no further treatment until the end of study (Maintenance II; Observation arm).
Maintenance II: Progression-free Survival (PFS) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia
NA Months
The endpoint could not be analyzed due to the limited number of PFS events
NA Months
Interval 39.75 to
The endpoint could not be analyzed due to the limited number of PFS events

SECONDARY outcome

Timeframe: From day of first rituximab induction dose up to day of disease progression, or discontinuation of treatment for any reason (up to approximately 87 months)

Population: The safety population included all participants who received at least one dose of study drug and had a safety assessment performed post randomization.

An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 (obtained retrospectively) were collected for this arm. Therefore arms are not comparable overall.

Outcome measures

Outcome measures
Measure
Maintenance II - Arm A (Rituximab)
n=692 Participants
Participants were randomized to receive SC rituximab administered as a single injection of 1400 mg fixed dose without chemotherapy every 8 weeks until disease progression or until the end of study.
Maintenance II - Arm B (Observation Only)
Participants were randomized to no longer receive SC rituximab but observed until the end of study.
All Participants
Participants were enrolled in an Induction period (up to 8 months) and received SC rituximab at a dose of 375 mg/m2 body surface area (BSA) followed by standard chemotherapy then continued into Maintenance I period (up to 24 months) and received SC rituximab of 1400 mg without chemotherapy. Participants who completed the Induction and Maintenance I periods with SC rituximab and for whom Partial Response (PR) or Complete Response (CR) was confirmed, were considered responders and were then randomized to receive either prolonged SC rituximab continued until disease progression or until the end of study (Maintenance II; Rituximab arm) or observation with no further treatment until the end of study (Maintenance II; Observation arm).
Number of Participants With Adverse Events (AEs), Serious AEs, and Infusion/Administration-related Reactions (IRRs/ARRs)
Number of Participants with Adverse Events
643 Participants
Number of Participants With Adverse Events (AEs), Serious AEs, and Infusion/Administration-related Reactions (IRRs/ARRs)
Number of Participants with Serious Adverse Events
339 Participants
Number of Participants With Adverse Events (AEs), Serious AEs, and Infusion/Administration-related Reactions (IRRs/ARRs)
Number of Participants with IRRs/ARRs
330 Participants

SECONDARY outcome

Timeframe: From day of first rituximab induction dose up to day of any treatment failure, including disease progression, or discontinuation of treatment for any reason (up to approximately 87 months)

Population: All participants who were enrolled into the given study period and had received at least one dose of study treatment at any time were included in the ITT population for each period of the study; Induction, Maintenance I and Maintenance I

Event-Free Survival was measured from the day of first rituximab Induction dose through Maintenance I and Maintenance II rituximab arm until the date of any treatment failure, including disease progression, or discontinuation of treatment for any reason (e.g. disease progression, toxicity, patient preference, initiation of new anti-lymphoma treatment, or death). Treatment discontinuation was considered as an event and was not applicable to the randomized observation arm.

Outcome measures

Outcome measures
Measure
Maintenance II - Arm A (Rituximab)
n=138 Participants
Participants were randomized to receive SC rituximab administered as a single injection of 1400 mg fixed dose without chemotherapy every 8 weeks until disease progression or until the end of study.
Maintenance II - Arm B (Observation Only)
n=692 Participants
Participants were randomized to no longer receive SC rituximab but observed until the end of study.
All Participants
Participants were enrolled in an Induction period (up to 8 months) and received SC rituximab at a dose of 375 mg/m2 body surface area (BSA) followed by standard chemotherapy then continued into Maintenance I period (up to 24 months) and received SC rituximab of 1400 mg without chemotherapy. Participants who completed the Induction and Maintenance I periods with SC rituximab and for whom Partial Response (PR) or Complete Response (CR) was confirmed, were considered responders and were then randomized to receive either prolonged SC rituximab continued until disease progression or until the end of study (Maintenance II; Rituximab arm) or observation with no further treatment until the end of study (Maintenance II; Observation arm).
Event-free Survival (Time to Treatment Failure) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia
65.38 Months
Interval 60.98 to
Not reached because the upper 95% CI of median could not be calculated based on Greenwood formula due to limited events.
24.99 Months
Interval 20.73 to 27.99

SECONDARY outcome

Timeframe: From day of first rituximab induction dose up to any new lymphoma treatment (up to approximately 87 months)

Population: The analysis population was the randomised ITT population (ITTrand), which included only randomised participants (Maintenance II only) as well as the ITT population, that included all participants who had completed a Baseline visit and at least one on-treatment assessment (Induction, Maintenance I and Maintenance II).

Time to next lymphoma treatment (TNLT) is defined as the time from date of first rituximab induction dose to the date date of first documented intake of any new antilymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc.).

Outcome measures

Outcome measures
Measure
Maintenance II - Arm A (Rituximab)
n=138 Participants
Participants were randomized to receive SC rituximab administered as a single injection of 1400 mg fixed dose without chemotherapy every 8 weeks until disease progression or until the end of study.
Maintenance II - Arm B (Observation Only)
n=138 Participants
Participants were randomized to no longer receive SC rituximab but observed until the end of study.
All Participants
n=692 Participants
Participants were enrolled in an Induction period (up to 8 months) and received SC rituximab at a dose of 375 mg/m2 body surface area (BSA) followed by standard chemotherapy then continued into Maintenance I period (up to 24 months) and received SC rituximab of 1400 mg without chemotherapy. Participants who completed the Induction and Maintenance I periods with SC rituximab and for whom Partial Response (PR) or Complete Response (CR) was confirmed, were considered responders and were then randomized to receive either prolonged SC rituximab continued until disease progression or until the end of study (Maintenance II; Rituximab arm) or observation with no further treatment until the end of study (Maintenance II; Observation arm).
Time to Next Lymphoma Treatment (TNLT)
NA Months
The end point could not be analyzed due to the limited number of events.
NA Months
The end point could not be analyzed due to a limited number of events. Biased as subjects stopped treatment and were likely to receive NLT earlier.
NA Months
The end point could not be analyzed due to the limited number of events.

SECONDARY outcome

Timeframe: From day of first rituximab induction dose up to death (up to approximately 87 months)

Population: The ITT population included all participants who had completed a Baseline visit and at least one on-treatment assessment and were enrolled into each period of the study; Induction, Maintenance I and Maintenance II.

Overall survival from first induction treatment (OSRegist) is defined as the time from date of first rituximab induction dose to the date of death, irrespective of cause. One participant died in Induction before randomization and one participant died in Maintenance II Observation arm due to an SAE and were not considered in the analysis as no death page was completed.

Outcome measures

Outcome measures
Measure
Maintenance II - Arm A (Rituximab)
n=692 Participants
Participants were randomized to receive SC rituximab administered as a single injection of 1400 mg fixed dose without chemotherapy every 8 weeks until disease progression or until the end of study.
Maintenance II - Arm B (Observation Only)
Participants were randomized to no longer receive SC rituximab but observed until the end of study.
All Participants
Participants were enrolled in an Induction period (up to 8 months) and received SC rituximab at a dose of 375 mg/m2 body surface area (BSA) followed by standard chemotherapy then continued into Maintenance I period (up to 24 months) and received SC rituximab of 1400 mg without chemotherapy. Participants who completed the Induction and Maintenance I periods with SC rituximab and for whom Partial Response (PR) or Complete Response (CR) was confirmed, were considered responders and were then randomized to receive either prolonged SC rituximab continued until disease progression or until the end of study (Maintenance II; Rituximab arm) or observation with no further treatment until the end of study (Maintenance II; Observation arm).
Overall Survival
NA Months
The end point could not be analyzed due to a limited number of events. Randomized arms pooled as it included information prior to randomization. Interpret with caution.

SECONDARY outcome

Timeframe: From randomization (Maintenance II) up to death (up to approximately 24 months)

Population: The analysis population was the randomised ITT population (ITTrand), which included only randomised participants (Maintenance II only) and was used for the analysis of the primary efficacy endpoint of PFS and the secondary analysis endpoint overall survival (OS).

Overall survival from randomization (OSrand) is defined as the time from date of randomization to the date of death, irrespective of cause.

Outcome measures

Outcome measures
Measure
Maintenance II - Arm A (Rituximab)
n=138 Participants
Participants were randomized to receive SC rituximab administered as a single injection of 1400 mg fixed dose without chemotherapy every 8 weeks until disease progression or until the end of study.
Maintenance II - Arm B (Observation Only)
n=138 Participants
Participants were randomized to no longer receive SC rituximab but observed until the end of study.
All Participants
Participants were enrolled in an Induction period (up to 8 months) and received SC rituximab at a dose of 375 mg/m2 body surface area (BSA) followed by standard chemotherapy then continued into Maintenance I period (up to 24 months) and received SC rituximab of 1400 mg without chemotherapy. Participants who completed the Induction and Maintenance I periods with SC rituximab and for whom Partial Response (PR) or Complete Response (CR) was confirmed, were considered responders and were then randomized to receive either prolonged SC rituximab continued until disease progression or until the end of study (Maintenance II; Rituximab arm) or observation with no further treatment until the end of study (Maintenance II; Observation arm).
Maintenance II: Overall Survival
NA Months
The end point could not be analyzed due to the limited number of events
NA Months
The end point could not be analyzed due to the limited number of events

SECONDARY outcome

Timeframe: From day of first rituximab induction dose up to end of induction period (up to approximately 8 months)

Population: The ITT population included all participants who had completed a Baseline visit and at least one on-treatment assessment and were enrolled into each period of the study; Induction, Maintenance I and Maintenance II.

Overall response rate is defined as the proportion of responders at the end of the Induction period. A responder is defined as a participant experiencing either CR or PR tumor response according to the Cheson response criteria for indolent lymphoma or the recommendations for Waldenström's macroglobulinemia.

Outcome measures

Outcome measures
Measure
Maintenance II - Arm A (Rituximab)
n=692 Participants
Participants were randomized to receive SC rituximab administered as a single injection of 1400 mg fixed dose without chemotherapy every 8 weeks until disease progression or until the end of study.
Maintenance II - Arm B (Observation Only)
Participants were randomized to no longer receive SC rituximab but observed until the end of study.
All Participants
Participants were enrolled in an Induction period (up to 8 months) and received SC rituximab at a dose of 375 mg/m2 body surface area (BSA) followed by standard chemotherapy then continued into Maintenance I period (up to 24 months) and received SC rituximab of 1400 mg without chemotherapy. Participants who completed the Induction and Maintenance I periods with SC rituximab and for whom Partial Response (PR) or Complete Response (CR) was confirmed, were considered responders and were then randomized to receive either prolonged SC rituximab continued until disease progression or until the end of study (Maintenance II; Rituximab arm) or observation with no further treatment until the end of study (Maintenance II; Observation arm).
Percentage of Participants With Partial or Complete Tumor Response (PR/CR) Assessment at End of Induction Using 1999 International Working Group Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia
84.7 Percentage of Participants
Interval 81.8 to 87.3

SECONDARY outcome

Timeframe: From day of first rituximab induction dose up to end of Maintenance I period (up to approximately 32 months)

Population: The Maintenance I participant analysis group consisted of a subgroup of responding participants who completed Induction and successfully enrolled into Maintenance I. Participants who had partial response (PR) at the end of Induction were included in this analysis.

Outcome measures

Outcome measures
Measure
Maintenance II - Arm A (Rituximab)
n=357 Participants
Participants were randomized to receive SC rituximab administered as a single injection of 1400 mg fixed dose without chemotherapy every 8 weeks until disease progression or until the end of study.
Maintenance II - Arm B (Observation Only)
Participants were randomized to no longer receive SC rituximab but observed until the end of study.
All Participants
Participants were enrolled in an Induction period (up to 8 months) and received SC rituximab at a dose of 375 mg/m2 body surface area (BSA) followed by standard chemotherapy then continued into Maintenance I period (up to 24 months) and received SC rituximab of 1400 mg without chemotherapy. Participants who completed the Induction and Maintenance I periods with SC rituximab and for whom Partial Response (PR) or Complete Response (CR) was confirmed, were considered responders and were then randomized to receive either prolonged SC rituximab continued until disease progression or until the end of study (Maintenance II; Rituximab arm) or observation with no further treatment until the end of study (Maintenance II; Observation arm).
Maintenance I: Percentage of Participants With Conversion of PR to CR Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia
21.6 Percentage
Interval 17.4 to 26.2

SECONDARY outcome

Timeframe: From day of first rituximab induction dose up to disease progression or death, whichever occurs first (up to approximately 87 months)

Population: The ITT population included all participants who had completed a Baseline visit and at least one on-treatment assessment and were enrolled into each period of the study; Induction, Maintenance I and Maintenance II.

Progression free survival from first induction treatment (PFSregist) is defined as the time from date of first rituximab induction dose to the date of first documented disease progression or death by any cause, whichever occurs first.

Outcome measures

Outcome measures
Measure
Maintenance II - Arm A (Rituximab)
n=692 Participants
Participants were randomized to receive SC rituximab administered as a single injection of 1400 mg fixed dose without chemotherapy every 8 weeks until disease progression or until the end of study.
Maintenance II - Arm B (Observation Only)
Participants were randomized to no longer receive SC rituximab but observed until the end of study.
All Participants
Participants were enrolled in an Induction period (up to 8 months) and received SC rituximab at a dose of 375 mg/m2 body surface area (BSA) followed by standard chemotherapy then continued into Maintenance I period (up to 24 months) and received SC rituximab of 1400 mg without chemotherapy. Participants who completed the Induction and Maintenance I periods with SC rituximab and for whom Partial Response (PR) or Complete Response (CR) was confirmed, were considered responders and were then randomized to receive either prolonged SC rituximab continued until disease progression or until the end of study (Maintenance II; Rituximab arm) or observation with no further treatment until the end of study (Maintenance II; Observation arm).
Progression-free Survival (PFS) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia
59.33 Months
Interval 50.33 to 71.36

Adverse Events

Arm A

Serious events: 59 serious events
Other events: 133 other events
Deaths: 10 deaths

Arm B (Observation Only)

Serious events: 58 serious events
Other events: 133 other events
Deaths: 8 deaths

All Participants

Serious events: 339 serious events
Other events: 643 other events
Deaths: 161 deaths

Serious adverse events

Serious adverse events
Measure
Arm A
n=138 participants at risk
Subjects received SC rituximab administered as a single injection of 1400 mg fixed dose without chemotherapy every 8 weeks until disease progression or until the end of study.
Arm B (Observation Only)
n=138 participants at risk
Subjects did not receive further rituximab treatment until the end of study.
All Participants
n=692 participants at risk
Participants were enrolled in an Induction period (up to 8 months) and received SC rituximab at a dose of 375 mg/m2 body surface area (BSA) followed by standard chemotherapy then continued into Maintenance I period (up to 24 months) and received SC rituximab of 1400 mg without chemotherapy. Participants who completed the Induction and Maintenance I periods with SC rituximab and for whom Partial Response (PR) or Complete Response (CR) was confirmed, were considered responders and were then randomized to receive either prolonged SC rituximab continued until disease progression or until the end of study (Maintenance II; Rituximab arm) or observation with no further treatment until the end of study (Maintenance II; Observation arm).
Infections and infestations
Viral infection
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Varicella
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Venous thrombosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Vena cava thrombosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Phlebitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Peripheral arterial occlusive disease
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Orthostatic hypotension
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Jugular vein thrombosis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Hypotension
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Hypertension
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Haemorrhagic vasculitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Haematoma
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Flushing
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Deep vein thrombosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Abdominal hernia repair
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Urticaria
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Toxic skin eruption
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Skin reaction
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Rash papular
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Rash
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Peau D'orange
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Throat irritation
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Lung disorder
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
1.4%
2/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Bronchospasm
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Asthma
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Menometrorrhagia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Urethral haemorrhage
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Ureterolithiasis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Haematuria
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Nephrolithiasis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Acute kidney injury
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Psychiatric disorders
Depression
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Psychiatric disorders
Delirium
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Transient ischaemic attack
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Syncope
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Presyncope
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Peripheral sensory neuropathy
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Ischaemic stroke
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Hemiplegic migraine
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Headache
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Haemorrhage intracranial
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Cognitive disorder
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Cerebrovascular disorder
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Cerebrovascular accident
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Cerebral infarction
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Cerebral haemorrhage
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Cerebral atrophy
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Carotid artery stenosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine adenocarcinoma
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Refractory Anaemia With An Excess Of Blasts
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodal Marginal Zone B-Cell Lymphoma
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Naevoid melanoma
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloid leukaemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.3%
9/692 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large cell lung cancer
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular Carcinoma
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the stomach
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anaplastic astrocytoma
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal squamous cell carcinoma
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Spinal column stenosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Haemarthrosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Compartment syndrome
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Back pain
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Tumour lysis syndrome
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Hypophosphataemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Neutrophil count decreased
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Lymphocyte count decreased
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Upper limb fracture
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Tooth avulsion
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Spinal compression fracture
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Pubis fracture
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Lumbar vertebral fracture
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Infusion related reaction
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.0%
7/692 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Hip fracture
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Head injury
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Femur fracture
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Femoral neck fracture
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Fall
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Complications of bone marrow transplant
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Chest injury
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Ankle fracture
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Anastomotic leak
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Viral upper respiratory tract infection
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Urosepsis
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Urinary tract infection
2.2%
3/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.7%
12/692 • Number of events 13 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Upper respiratory tract infection
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.2%
8/692 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Tracheobronchitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Soft tissue infection
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Skin infection
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Septic shock
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Sepsis syndrome
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Sepsis
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.6%
18/692 • Number of events 18 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Salmonellosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Respiratory tract infection
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.3%
9/692 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Pyelonephritis chronic
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Pulmonary sepsis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Pseudomonas infection
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Progressive multifocal leukoencephalopathy
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Pneumonia
10.1%
14/138 • Number of events 14 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
4.3%
6/138 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
7.8%
54/692 • Number of events 65 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Pneumocystis Jirovecii pneumonia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Pneumococcal infection
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Pharyngitis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Periorbital cellulitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Perineal cellulitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Paraspinal abscess
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Neutropenic sepsis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Necrotising fasciitis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Myocarditis septic
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Myocarditis infectious
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Meningitis aseptic
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Lung infection
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.9%
4/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.0%
7/692 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Lower respiratory tract infection
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.6%
5/138 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
10/692 • Number of events 11 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Kidney infection
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Intestinal sepsis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Influenza
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Infection
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Herpes zoster
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Hepatitis viral
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Hepatitis C
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Hepatic candidiasis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Haemophilus infection
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Gastrointestinal infection
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Gastroenteritis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Escherichia urinary tract infection
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Erysipelas
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Enterobacter sepsis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Diverticulitis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Device related sepsis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Cytomegalovirus infection
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Cellulitis
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Candida infection
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Campylobacter gastroenteritis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Bronchopulmonary aspergillosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Bronchitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.9%
4/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Appendicitis
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Abscess
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Abdominal wall abscess
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Abdominal infection
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Immune system disorders
Immunosupression
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Immune system disorders
Hypersensitivity
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Immune system disorders
Drug hypersensitivity
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Hepatobiliary disorders
Liver disorder
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Hepatobiliary disorders
Jaundice
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Hepatobiliary disorders
Hepatic steatosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Hepatobiliary disorders
Hepatic failure
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Hepatobiliary disorders
Cholecystitis acute
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Hepatobiliary disorders
Cholecystitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Hepatobiliary disorders
Cholangitis acute
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Hepatobiliary disorders
Bile duct stone
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Sudden death
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Pyrexia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.6%
11/692 • Number of events 16 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Oedema peripheral
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Malaise
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Injection site reaction
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Injection site pain
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Injection site induration
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Injection site haematoma
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Injection site erythema
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Infusion site erythema
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Inflammation
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
General physical health deterioration
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Feeling hot
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Face oedema
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Death
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Chills
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Chest pain
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Vomiting
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Retroperitoneal haematoma
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Proctitis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Pancreatitis acute
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Pancreatitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Oesophagitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Intestinal pseudo-obstruction
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Inflammatory bowel disease
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Haemorrhoidal haemorrhage
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Gastrointestinal toxicity
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Gastritis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Dyspepsia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Duodenal ulcer
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Diverticular perporation
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Diarrhoea
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
10/692 • Number of events 12 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Crohn's disease
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Colitis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Ascites
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Abdominal pain
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Eye disorders
Dacryostenosis acquired
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Eye disorders
Cataract
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Endocrine disorders
Thyrotxic crisis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Endocrine disorders
Goitre
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Ear and labyrinth disorders
Vertigo positional
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Ear and labyrinth disorders
Vertigo
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Congenital, familial and genetic disorders
Atrial septal defect
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Ventricular tachycardia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Myocardial ischaemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Myocardial infarction
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Coronary artery disease
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Congestive cardiomyopathy
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Cardiopulmonary failure
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Cardiac failure congestive
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Cardiac failure acute
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Cardiac failure
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Cardic arrest
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Atrial fibrillation
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.0%
7/692 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Aortic valve incompetence
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Aortic valve calcification
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Acute myocardial infarction
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Acute coronary syndrome
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Neutropenia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
4.3%
6/138 • Number of events 12 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.2%
22/692 • Number of events 29 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Lymphopenia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Leukopenia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Hyperviscosity syndrome
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Febrile Neutropenia
2.9%
4/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
5.2%
36/692 • Number of events 42 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Bone marrow failure
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Anaemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.2%
8/692 • Number of events 10 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.

Other adverse events

Other adverse events
Measure
Arm A
n=138 participants at risk
Subjects received SC rituximab administered as a single injection of 1400 mg fixed dose without chemotherapy every 8 weeks until disease progression or until the end of study.
Arm B (Observation Only)
n=138 participants at risk
Subjects did not receive further rituximab treatment until the end of study.
All Participants
n=692 participants at risk
Participants were enrolled in an Induction period (up to 8 months) and received SC rituximab at a dose of 375 mg/m2 body surface area (BSA) followed by standard chemotherapy then continued into Maintenance I period (up to 24 months) and received SC rituximab of 1400 mg without chemotherapy. Participants who completed the Induction and Maintenance I periods with SC rituximab and for whom Partial Response (PR) or Complete Response (CR) was confirmed, were considered responders and were then randomized to receive either prolonged SC rituximab continued until disease progression or until the end of study (Maintenance II; Rituximab arm) or observation with no further treatment until the end of study (Maintenance II; Observation arm).
Skin and subcutaneous tissue disorders
Pruritus generalised
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Pruritus
8.0%
11/138 • Number of events 14 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
6.5%
9/138 • Number of events 12 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
7.4%
51/692 • Number of events 61 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Pruritus allergic
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Venous thrombosis limb
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Venous thrombosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Varicose vein
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Varicose ulceration
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Thrombosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Thrombophlebitis superficial
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Thrombophlebitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Subclavian vein thrombosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Spider vein
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Poor venous access
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Phlebitis superficial
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Phlebitis
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Peripheral venous disease
2.2%
3/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Peripheral ischaemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Peripheral coldness
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Peripheral arterial occlusive disease
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Pallor
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Orthostatic hypotension
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Ischaemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Intermittent claudication
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Hypotension
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.7%
19/692 • Number of events 21 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Hypertensive crisis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Hypertension
13.0%
18/138 • Number of events 27 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.6%
5/138 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
6.5%
45/692 • Number of events 57 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Hyperaemia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Hot flush
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.2%
8/692 • Number of events 16 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Haemorrhage
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Haematoma
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Flushing
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.2%
8/692 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Essential hypertension
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Embolism
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Deep vein thrombosis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Aortic stenosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/692 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Aortic arteriosclerosis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Aortic aneurysm
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Angiopathy
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Vascular disorders
Arteriosclerosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Tooth extraction
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Skin neoplasm excision
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Shoulder arthroplasty
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Nephrostomy
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Mass excision
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Hip arthroplasty
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Foot operation
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Cholecystectomy
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Central venous catheter removal
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Cataract operation
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.9%
4/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Astringent therapy
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Urticaria
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
15/692 • Number of events 20 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Swelling face
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Stasis dermatitis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Skin ulcer
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Skin swelling
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Skin reaction
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Skin mass
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Skin lesion
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
5.1%
7/138 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.7%
19/692 • Number of events 22 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Skin exfoliation
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Skin disorder
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Sebaceous hyperplasia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Rosacea
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Rash pruritic
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Rash papular
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.2%
8/692 • Number of events 10 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Rash macular
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Rash generalised
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Rash follicular
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Rash erythematous
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.0%
7/692 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Rash
13.8%
19/138 • Number of events 24 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
13.0%
18/138 • Number of events 23 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
11.0%
76/692 • Number of events 97 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Purpura
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Psoriasis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Prurigo
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Pityriasis rosea
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Perioral dermatitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Panniculitis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Pain of skin
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Night sweats
2.2%
3/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.7%
19/692 • Number of events 22 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Neurodermatitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Nail discolouration
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Macule
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Intertrigo
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Hypertrichiosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Hyperkeratosis
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.2%
8/692 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Hyperhidrosis
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
15/692 • Number of events 15 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Granulomatous rosacea
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Exfoliative rash
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Erythema nodosum
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Erythema multiforme
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Eczema nummular
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Ecchymosis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Eczema
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.9%
4/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.7%
12/692 • Number of events 14 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Erythema
4.3%
6/138 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
4.3%
6/138 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
4.2%
29/692 • Number of events 39 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Dry skin
2.9%
4/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
10/692 • Number of events 11 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Drug eruption
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Dermatomyositis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Dermatitis bullous
0.72%
1/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Dermatitis atopic
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Dermatitis allergic
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Dermatitis
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Dermal cyst
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Decubitus ulcer
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Blood blister
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Angioedema
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Alopecia
4.3%
6/138 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
4.3%
6/138 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.3%
23/692 • Number of events 26 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Actinic keratosis
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
10/692 • Number of events 11 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Skin and subcutaneous tissue disorders
Acne
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Wheezing
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Upper airway obstruction
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Tracheomalacia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Throat tightness
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Throat irritation
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Sneezing
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Sinus polyp
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Sinus disorder
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Sinus congestion
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Rhonchi
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
4.3%
6/138 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.0%
14/692 • Number of events 14 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Rhinitis atrophic
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.6%
11/692 • Number of events 11 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Rales
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Productive cough
3.6%
5/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
5.8%
8/138 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.6%
25/692 • Number of events 28 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Pleurisy
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Pharyngeal parasthesia
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Painful respiration
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Orthopnoea
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
10.9%
15/138 • Number of events 15 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.6%
5/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
5.6%
39/692 • Number of events 40 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Obliterative bronchiolitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Noninfective bronchitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Nasal pruritus
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Nasal polyps
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.2%
8/692 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Lung disorder
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Larynx irritation
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Laryngospasm
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Hiccups
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Epistaxis
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.7%
12/692 • Number of events 15 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Emphysema
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
4.3%
6/138 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
8.0%
11/138 • Number of events 11 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
7.9%
55/692 • Number of events 62 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Dysphonia
4.3%
6/138 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.0%
14/692 • Number of events 18 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Dry throat
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Cough
34.1%
47/138 • Number of events 72 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
17.4%
24/138 • Number of events 37 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
19.5%
135/692 • Number of events 185 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
3.6%
5/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.3%
9/692 • Number of events 10 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Catarrh
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Bronchospasm
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.0%
7/692 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Bronchomalacia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Bronchial disorder
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Atelectasis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Asthma
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Vulvovaginal erythema
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Vaginal discharge
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Testicular pain
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Testicular oedema
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Pruritus genital
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Premature menopause
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Pelvic pain
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Pelvic discomfort
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Ovarian cyst
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Menstrual disorder
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Erectile dysfunction
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Dysmenorrhoea
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Cystocele
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Benign prostatic hyperplasia
2.9%
4/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Amenorrhoea
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Urinary tract pain
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Urinary tract obstruction
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Urinary retention
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Puncture site abscess
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Urinary incontinence
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Urethral haemorrhage
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Strangury
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Renal pain
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Renal impairment
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Renal failure
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.2%
8/692 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Renal cyst
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Renal colic
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Renal atrophy
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Polyuria
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Pollakiuria
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.3%
9/692 • Number of events 10 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Nocturia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Nephrolithiasis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Nephroangiosclerosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Micturition urgency
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Leukocyturia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Hypertonic bladder
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Haematuria
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Dysuria
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
4.3%
6/138 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.9%
13/692 • Number of events 14 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Cystitis haemorrhagic
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Chronic kidney disease
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Bladder hypertrophy
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Bladder disorder
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Azotaemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Renal and urinary disorders
Acute kidney injury
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Psychiatric disorders
Stress
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Psychiatric disorders
Sleep disorder
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Psychiatric disorders
Restlessness
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Psychiatric disorders
Panic attack
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Psychiatric disorders
Mood altered
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Psychiatric disorders
Loss of libido
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Psychiatric disorders
Insomnia
5.1%
7/138 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.6%
5/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
4.5%
31/692 • Number of events 33 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Psychiatric disorders
Feeling of despair
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Psychiatric disorders
Depression
5.8%
8/138 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.9%
20/692 • Number of events 20 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Psychiatric disorders
Depressed mood
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Psychiatric disorders
Delirium
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Psychiatric disorders
Confusional state
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Psychiatric disorders
Anxiety disorder
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Psychiatric disorders
Anxiety
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
6.5%
9/138 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.2%
22/692 • Number of events 23 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Psychiatric disorders
Agitation
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Psychiatric disorders
Adjustment disorder with depressed mood
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Vertebrobasilar insufficiency
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Tremor
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.9%
13/692 • Number of events 15 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Tension headache
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Syncope
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
10/692 • Number of events 10 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Somnolence
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Sensory disturbance
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Sensorimotor disorder
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Seizure
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Sciatica
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.9%
4/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.7%
12/692 • Number of events 14 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Presyncope
2.9%
4/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Post herpetic neuralgia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Polyneuropathy
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Peripheral sensory neuropathy
2.9%
4/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
10/692 • Number of events 10 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Peripheral sensorimotor neuropathy
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Parosmia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Parkinsonism
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Paraesthesia
3.6%
5/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
6.5%
9/138 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
4.2%
29/692 • Number of events 29 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Nystagmus
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Neuropathy peripheral
5.8%
8/138 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
5.1%
7/138 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.3%
23/692 • Number of events 25 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Neuromuscular pain
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Neuralgia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Nerve root compression
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Nerve compression
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Memory impairment
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Lumbar radiculopathy
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Lethargy
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Intention tremor
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Hypotonia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Hypokinesia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Hypoaesthesia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Hypersomnia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Hemiparesis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Headache
11.6%
16/138 • Number of events 24 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
13.0%
18/138 • Number of events 25 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
9.8%
68/692 • Number of events 92 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Formication
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Facial paralysis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Facial neuralgia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Dysgraphia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Dysgeusia
5.1%
7/138 • Number of events 11 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.5%
17/692 • Number of events 21 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Dysaesthesia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Dizziness
11.6%
16/138 • Number of events 21 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
5.8%
8/138 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
5.2%
36/692 • Number of events 42 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Disturbance in attention
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Diabetic neuropathy
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Cluster headache
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Cerebral microangiopathy
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Cerebral ischaemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Carpal tunnel syndrome
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Carotid arteriosclerosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Burning sensation
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Balance disorder
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Ataxia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Arachnoid cyst
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Aphonia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Aphasia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Anosmia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Amnesia
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Nervous system disorders
Ageusia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sweat gland tumour
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.0%
7/692 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
0.72%
1/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paget's disease of nipple
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lobular breast carcinoma in situ
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine benign neoplasm
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large cell lung cancer
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
3.6%
5/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.6%
5/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.5%
17/692 • Number of events 19 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Tenosynovitis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Tendonitis
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Tendon disorder
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Synovial cyst
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Spondylitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Spinal pain
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Spinal column stenosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Polyarthritis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Periostitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Periarthritis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Pain in jaw
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Pain in extremity
7.2%
10/138 • Number of events 10 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
7.2%
10/138 • Number of events 11 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
6.2%
43/692 • Number of events 46 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Osteoporosis
2.9%
4/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.0%
7/692 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Osteopenia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Osteochondrosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Osteoarthritis
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.6%
5/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.0%
14/692 • Number of events 15 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Osteitis deformans
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Neck pain
2.9%
4/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.6%
11/692 • Number of events 12 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Myalgia
3.6%
5/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.6%
5/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.3%
16/692 • Number of events 17 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
3.6%
5/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
4.3%
6/138 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.2%
22/692 • Number of events 22 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Muscle tightness
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Muscle spasms
7.2%
10/138 • Number of events 10 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.6%
5/138 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.6%
25/692 • Number of events 28 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Muscle fatigue
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Muscle contracture
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Mobility decreased
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Limb mass
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Limb discomfort
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Joint swelling
1.4%
2/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.0%
7/692 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Joint stiffness
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Groin pain
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Foot deformity
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Flank pain
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Exostosis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Chondrocalcinosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Bursitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Bone pain
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.5%
17/692 • Number of events 17 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Back pain
10.1%
14/138 • Number of events 16 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
9.4%
13/138 • Number of events 19 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
9.0%
62/692 • Number of events 72 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Axillary mass
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Arthralgia
10.9%
15/138 • Number of events 22 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
10.1%
14/138 • Number of events 23 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
7.5%
52/692 • Number of events 68 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Vitamin D deficiency
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Vitamin B12 deficiency
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Type 2 diabetes mellitus
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Tumour lysis syndrome
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Tetany
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Obesity
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Metabolic disorder
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Metabolic acidosis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Malnutrition
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Lactose intolerance
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Iron deficiency
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Increased appetite
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Hypovitaminosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Hypouricaemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Hypoproteinaemia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Hypophosphataemia
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.0%
7/692 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Hypophagia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Hyponatraemia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Hypomagnesaemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Hypokalaemia
5.1%
7/138 • Number of events 10 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.2%
22/692 • Number of events 31 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Hypoalbminaemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Hyperuricaemia
4.3%
6/138 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
10/692 • Number of events 13 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Hypertriglyceridaemia
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Hyperphosphataemia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Hypernatraemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Hyperlipidaemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Hyperkalaemia
1.4%
2/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Hyperglycaemia
1.4%
2/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.2%
8/692 • Number of events 11 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Hypercholesterolaemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Hypercalcaemia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Gout
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Folate deficiency
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Fluid retention
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Fluid overload
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Dyslipidaemia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Diabetes mellitus
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.0%
7/692 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Decreased appetite
5.1%
7/138 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
5.1%
7/138 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
6.9%
48/692 • Number of events 56 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Metabolism and nutrition disorders
Cachexia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
White blood cell count increased
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
White blood cell count decreased
8.0%
11/138 • Number of events 19 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
9.4%
13/138 • Number of events 21 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
6.6%
46/692 • Number of events 72 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Weight increased
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Weight decreased
4.3%
6/138 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.9%
4/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.6%
25/692 • Number of events 27 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Transferrin saturation decreased
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Transaminases increased
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Pulse abnormal
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Prostatic specific antigen increased
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Polymerase chain reaction positive
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Platelet count increased
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Platelet count decreased
10.1%
14/138 • Number of events 20 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
7.2%
10/138 • Number of events 13 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
8.5%
59/692 • Number of events 96 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Oxygen saturation decrease
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Neutrophil count increased
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Neutrophil count decreased
20.3%
28/138 • Number of events 65 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
21.0%
29/138 • Number of events 60 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
16.3%
113/692 • Number of events 289 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Lymphocyte count increased
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Lymphocyte count decreased
9.4%
13/138 • Number of events 17 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
10.1%
14/138 • Number of events 23 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
6.5%
45/692 • Number of events 80 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Liver palpable
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Liver function test increased
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
International normalised ratio increased
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
International normalised ratio decreased
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Immunoglobulins decreased
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Hypophonesis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Histamine level increased
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Hepatic enzyme increased
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Haemoglobin decreased
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Gamma-glutamyltransferase increased
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Eosinophil count increased
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Electrocardiogram QT prolonged
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Ejection fraction decreased
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Coagulation time prolonged
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Cardiac murmur
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
CD4 lymphocytes decreased
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
C-reactive protein increased
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.5%
17/692 • Number of events 17 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Body temperature increased
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Blood urea increased
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Blood sodium decreased
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Blood pressure increased
0.72%
1/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Blood pressure abnormal
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Blood potassium decreased
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Blood phosphorus decreased
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Blood magnesium decreased
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Blood lactate dehydrogenase increased
2.9%
4/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.0%
14/692 • Number of events 16 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Blood iron decreased
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Blood immunoglobulin M decreased
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Blood immunoglobulin G decreased
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Blood glucose increased
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Blood folate decreased
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Blood creatinine increased
2.9%
4/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.9%
4/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.7%
12/692 • Number of events 17 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Blood creatine increased
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Blood cholesterol increased
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Blood bilirubin increased
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Blood alkaline phosphatase increased
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.2%
8/692 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Biopsy prostate
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Aspartate aminotransferase increased
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.6%
11/692 • Number of events 13 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Investigations
Alanine aminotransferase increased
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.6%
11/692 • Number of events 20 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Wrist fracture
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Upper limb fracture
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Traumatic haematoma
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Toxicity to various agents
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Tooth fracture
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Tooth avulsion
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Thermal burn
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Spinal fracture
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Spinal compression fracture
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Skin abrasion
1.4%
2/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Scratch
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Rib fracture
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Radius fracture
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Radiation skin injury
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Radiation injury
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Procedural site reaction
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Procedural pain
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Post-traumatic pain
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Post procedural haematoma
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Pelvic fracture
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Muscle strain
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Muscle rupture
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Medication error
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Lumbar vertebral fracture
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Limb injury
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Ligament sprain
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Ligament rupture
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Laceration
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Joint injury
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Joint dislocation
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Infusion related reaction
2.9%
4/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.3%
23/692 • Number of events 24 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Humerus fracture
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Head injury
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Hand fracture
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Fracture
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Foot fracture
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Fall
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.9%
4/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.6%
11/692 • Number of events 12 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Epicondylitis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Dental restoration failure
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Craniocerebral injury
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Contusion
2.9%
4/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Arthropod bite
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Animal bite
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Injury, poisoning and procedural complications
Administration related reaction
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Wound infection
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Vulvovaginal mycotic infection
0.72%
1/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Vulvitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Viral upper respiratory tract infection
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.0%
7/692 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Viral pharyngitis
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Viral parotitis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Viral infection
5.1%
7/138 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.6%
11/692 • Number of events 12 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Varicella zoster virus infection
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Vaginal infection
1.4%
2/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Urinary tract infection
8.0%
11/138 • Number of events 14 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
10.1%
14/138 • Number of events 22 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
7.9%
55/692 • Number of events 73 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Ureaplasma infection
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Upper respiratory tract infection
17.4%
24/138 • Number of events 36 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
14.5%
20/138 • Number of events 26 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
9.1%
63/692 • Number of events 85 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Trichomoniasis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Tracheobronchitis
2.9%
4/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Tracheitis
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.2%
8/692 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Tooth infection
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Tooth abscess
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Tonsillitis
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Tinea pedis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Superinfection
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Subcutaneous abscess
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Staphylococcal infection
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Skin infection
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Sinusitis bacterial
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Sinusitis
10.1%
14/138 • Number of events 27 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
11.6%
16/138 • Number of events 21 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
6.5%
45/692 • Number of events 67 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Sepsis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Rhinitis
13.8%
19/138 • Number of events 21 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
6.5%
9/138 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
6.1%
42/692 • Number of events 46 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Respiratory tract infection viral
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Respiratory tract infection
2.9%
4/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
7.2%
10/138 • Number of events 19 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.5%
24/692 • Number of events 36 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Respiratory syncytial virus infection
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Rectal abscess
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Rash pustular
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Pyoderma
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Pyelonephritis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Pulpitis dental
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Pseudomonas infection
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Pseudomembranous colitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Proteus infection
0.72%
1/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Postoperative wound infection
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Pneumonia fungal
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Pneumonia bacterial
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Pneumonia
12.3%
17/138 • Number of events 22 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
7.2%
10/138 • Number of events 13 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
6.4%
44/692 • Number of events 55 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Pharyngotonsillitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Pharyngitis
2.2%
3/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.3%
9/692 • Number of events 13 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Pertussis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Periorbital infection
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Paronychia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Parainfluenzae virus infection
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Otitis media
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Otitis externa
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Oral infection
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Oral herpes
6.5%
9/138 • Number of events 17 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.9%
4/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.6%
25/692 • Number of events 35 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Oral fungal infection
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Oral candidiasis
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.0%
14/692 • Number of events 15 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Orchitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Onychomycosis
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Oesophageal candidiasis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Nasopharyngitis
21.0%
29/138 • Number of events 55 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
17.4%
24/138 • Number of events 36 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
10.4%
72/692 • Number of events 120 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Nasal herpes
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Nail infection
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Mucosal infection
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Meningitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
100.0%
1/1 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Lymphangitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Lung infection
7.2%
10/138 • Number of events 15 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.6%
5/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.5%
24/692 • Number of events 32 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Lower respiratory tract infection viral
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Lower respiratory tract infection
12.3%
17/138 • Number of events 37 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
6.5%
9/138 • Number of events 14 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
6.6%
46/692 • Number of events 76 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Lip infection
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Laryngitis
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Labyrinthitis
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Injection site cellulitis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Influenza
14.5%
20/138 • Number of events 23 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
10.1%
14/138 • Number of events 18 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
8.1%
56/692 • Number of events 65 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Infectious colitis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Infection
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Infected bite
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Hordeolum
1.4%
2/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Herpes zoster oticus
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Herpes zoster infection neurological
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Herpes zoster
11.6%
16/138 • Number of events 18 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
8.7%
12/138 • Number of events 12 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
6.6%
46/692 • Number of events 50 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Herpes virus infection
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Herpes simplex
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Hepatitis viral
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Hepatitis B
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Hepatic infection fungal
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Helicobacter gastritis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Haemophilus infection
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Gingivitis
1.4%
2/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Genital herpes simplex
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Gastrointestinal infection
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Gastrointestinal fungal infection
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Gastroenteritis viral
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Gastroenteritis salmonella
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Gastroenteritis
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
5.1%
7/138 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.6%
11/692 • Number of events 12 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Furuncle
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Fungal skin infection
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Fungal infection
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Folliculitis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.2%
8/692 • Number of events 12 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Eyelid infection
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Eye infection
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Escherichia urinary tract infection
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Erysipelas
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Epstein-Barr virus infection
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Endocarditis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Ear infection
2.2%
3/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.9%
4/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.0%
14/692 • Number of events 17 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Diverticulitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Diarrhoea infectious
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Device related sepsis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Device related infection
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Dacryocanaliculitis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Cytomegalovirus infection
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Cystitis Escherichia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Cystitis
2.9%
4/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Conjunctivitis
8.7%
12/138 • Number of events 14 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.9%
4/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.5%
24/692 • Number of events 27 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Chlamydial infection
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Cellulitis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.2%
8/692 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Candida infection
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Campylobacter infection
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Campylobacter gastroenteritis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Campylobacter colitis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Bronchitis
17.4%
24/138 • Number of events 55 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
15.2%
21/138 • Number of events 27 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
11.3%
78/692 • Number of events 126 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Body tinea
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Blastocystis infection
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Bartholinitis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Balanitis candida
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Bacteriuria
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Bacterial infection
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Arthritis infective
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Arthritis bacterial
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Application site cellulitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Angular cheilitis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Anal abscess
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Acute sinusitis
3.6%
5/138 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.0%
7/692 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Abscess oral
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Infections and infestations
Abdominal infection
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Immune system disorders
Seasonal allergy
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Immune system disorders
Sarcoidosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Immune system disorders
Iodine allergy
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Immune system disorders
Immunodeficiency
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Immune system disorders
Immune system disorder
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Immune system disorders
Hypogammaglobulinaemia
6.5%
9/138 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
6.5%
9/138 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.8%
26/692 • Number of events 26 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Immune system disorders
Hypersensitivity
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.0%
7/692 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Immune system disorders
Drug hypersensitivity
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Immune system disorders
Cytokine release syndrome
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Xerosis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Vessel puncture site haematoma
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Unevaluable event
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Thirst
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Swelling
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Pyrexia
23.2%
32/138 • Number of events 45 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
21.0%
29/138 • Number of events 49 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
23.0%
159/692 • Number of events 258 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Puncture site pain
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Puncture site erythema
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Polyp
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Peripheral swelling
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.0%
7/692 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Performance status decreased
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Pain
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.2%
8/692 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Oedema peripheral
4.3%
6/138 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
5.1%
7/138 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
5.5%
38/692 • Number of events 40 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Oedema
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.3%
9/692 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Mucosal inflammation
4.3%
6/138 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
5.1%
7/138 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.6%
25/692 • Number of events 27 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Malaise
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
10/692 • Number of events 10 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Localised oedema
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Injection site warmth
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Injection site thrombosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Injection site swelling
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Injection site reaction
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
10/692 • Number of events 13 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Injection site rash
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.2%
8/692 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Injection site pruritus
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Injection site plaque
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Injection site pain
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
4.3%
6/138 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.5%
24/692 • Number of events 34 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Injection site oedema
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Injection site mass
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Injection site irritation
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Injection site inflammation
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.2%
8/692 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Injection site induration
2.2%
3/138 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 17 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Injection site hypersensitivity
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Injection site haematoma
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Injection site erythema
7.2%
10/138 • Number of events 11 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
6.5%
9/138 • Number of events 14 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
5.5%
38/692 • Number of events 46 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Injection site discomfort
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Injection site discolouration
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Injection site bruising
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Infusion site rash
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Infusion site pain
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Infusion site inflammation
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Infusion site haematoma
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Infusion site extravasation
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Infusion site erythema
0.72%
1/138 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 16 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Influenza like illness
4.3%
6/138 • Number of events 24 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
4.3%
6/138 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.9%
20/692 • Number of events 45 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Inflammation
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Implant site haematoma
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Hypothermia
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Hyperthermia
2.2%
3/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.0%
7/692 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Haemorrhagic cyst
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Granuloma
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
General physical health deterioration
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Feeling of body temperature change
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Feeling hot
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Feeling cold
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Feeling abnormal
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Fatigue
21.7%
30/138 • Number of events 46 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
13.8%
19/138 • Number of events 25 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
16.6%
115/692 • Number of events 157 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Facial pain
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Face oedema
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Discomfort
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Cyst
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Chills
5.8%
8/138 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
6.5%
9/138 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
5.8%
40/692 • Number of events 47 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Chest pain
8.0%
11/138 • Number of events 12 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
5.1%
7/138 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.9%
27/692 • Number of events 29 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Chest discomfort
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
10/692 • Number of events 10 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Catheter site thrombosis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Catheter site haemorrhage
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Axillary pain
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Asthenia
19.6%
27/138 • Number of events 43 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
13.8%
19/138 • Number of events 28 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
16.3%
113/692 • Number of events 167 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Application site pain
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Application site erythema
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Administration site pain
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Administration site inflammation
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
General disorders
Administration site extravasation
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Vomiting
16.7%
23/138 • Number of events 32 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
11.6%
16/138 • Number of events 31 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
13.9%
96/692 • Number of events 160 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Umbilical hernia
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Toothache
3.6%
5/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.3%
9/692 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Tooth loss
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Tooth disorder
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Tooth development disorder
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Tongue ulceration
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Tongue geographic
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Tongue coated
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Stomatitis
3.6%
5/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.5%
17/692 • Number of events 18 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Sensitivity of teeth
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Salivary hypersecretion
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Rectal polyp
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Proctalgia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Perianal erythema
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Paraesthesia oral
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Pancreatic duct dilatation
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Pancreatic cyst
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Oral pain
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.6%
5/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
15/692 • Number of events 16 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Oral disorder
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Oesophagitis
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Odynophagia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.0%
7/692 • Number of events 10 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Noninfective gingivitis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Nausea
32.6%
45/138 • Number of events 63 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
26.8%
37/138 • Number of events 65 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
28.8%
199/692 • Number of events 312 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Mouth ulceration
2.2%
3/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.7%
12/692 • Number of events 15 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Melaena
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Lip ulceration
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Large intestinal ulcer
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Irritable bowel syndrome
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Intestinal obstruction
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Inguinal hernia
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Impaired gastric emptying
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Ileal ulcer
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Hiatus hernia
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Haemorrhoids thrombosed
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Haemorrhoids
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.7%
12/692 • Number of events 12 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Haemorrhoidal haemorrhage
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Haematochezia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Gingival bleeding
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Gastrooesophageal reflux disease
8.0%
11/138 • Number of events 13 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
5.1%
7/138 • Number of events 9 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.9%
20/692 • Number of events 24 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Gastrointestinal toxicity
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Gastrointestinal sounds abnormal
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Gastrointestinal inflammation
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Gastrointestinal hypomotility
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Gastrointestinal disorder
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Gastritis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
4.3%
6/138 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.7%
12/692 • Number of events 12 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Gastric ulcer
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Food poisoning
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Flatulence
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.0%
7/692 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Faeces soft
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Faecaloma
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Eructation
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Epigastric discomfort
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Enterocolitis
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Dysphagia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
10/692 • Number of events 10 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Dyspepsia
7.2%
10/138 • Number of events 10 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
5.1%
7/138 • Number of events 7 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
3.8%
26/692 • Number of events 27 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Dyschezia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Dry mouth
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
10/692 • Number of events 10 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Diverticulum intestinal
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Diarrhoea
25.4%
35/138 • Number of events 50 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
20.3%
28/138 • Number of events 36 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
20.7%
143/692 • Number of events 211 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Defaecation urgency
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Crohn's disease
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Constipation
15.2%
21/138 • Number of events 26 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
10.9%
15/138 • Number of events 22 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
14.2%
98/692 • Number of events 129 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Colitis
2.2%
3/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Chronic gastritis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Change in bowel habit
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Ascites
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Aphthous ulcer
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Anal haemorrhage
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Anal fissure
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Abdominal tenderness
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Abdominal pain upper
8.0%
11/138 • Number of events 16 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.9%
4/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
5.6%
39/692 • Number of events 49 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Abdominal pain lower
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Abdominal pain
9.4%
13/138 • Number of events 15 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
9.4%
13/138 • Number of events 23 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
8.2%
57/692 • Number of events 74 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Abdominal distension
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.0%
7/692 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Eye disorders
Vitreous floaters
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Eye disorders
Visual impairment
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Eye disorders
Visual acuity reduced
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Eye disorders
Vision blurred
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Eye disorders
Periorbital oedema
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Eye disorders
Ocular hyperaemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Eye disorders
Noninfective conjunctivitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Eye disorders
Lacrimation increased
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Eye disorders
Glaucoma
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Eye disorders
Eyelid swelling
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Eye disorders
Eyelid oedema
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Eye disorders
Eye pruritus
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Eye disorders
Eye pain
2.9%
4/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.87%
6/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Eye disorders
Eye irritation
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Eye disorders
Eye inflammation
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Eye disorders
Eye discharge
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Eye disorders
Entropion
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Eye disorders
Dry eye
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Eye disorders
Diabetic retinopathy
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Eye disorders
Conjunctivitis allergic
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Eye disorders
Conjunctival hyperaemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Eye disorders
Chalazion
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Eye disorders
Cataract
1.4%
2/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Ear and labyrinth disorders
Vestibular disorder
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Ear and labyrinth disorders
Vertigo
5.1%
7/138 • Number of events 10 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.6%
18/692 • Number of events 21 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Ear and labyrinth disorders
Tympanic membrane disorder
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Ear and labyrinth disorders
Tinnitus
3.6%
5/138 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.3%
9/692 • Number of events 10 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Ear and labyrinth disorders
Middle ear inflammation
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Ear and labyrinth disorders
Hypoacusis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Ear and labyrinth disorders
Ear pain
2.9%
4/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.6%
11/692 • Number of events 12 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Ear and labyrinth disorders
Deafness unilateral
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Ear and labyrinth disorders
Deafness
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Vantricular arrhythmia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Tachycardia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.9%
4/138 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
10/692 • Number of events 10 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Supraventricular tachycardia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Sinus tachycardia
1.4%
2/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Sinus bradycardia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Pericardial effusion
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Palpitations
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.9%
4/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.3%
9/692 • Number of events 11 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Myocardial ischaemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Mitral valve incompetence
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Left ventricular failure
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Left ventricular dysfunction
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Hyperkinetic heart syndrome
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Extrasystoles
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Cardiac failure congestive
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Cardiac failure chronic
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Cardiac failure
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Bundle branch block left
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Bradycardia
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Atrioventricular block complete
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Atrial tachycardia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Atrial fibrillation
1.4%
2/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.2%
8/692 • Number of events 12 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Atrial flutter
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Arrhythmia supraventricular
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Arrhythmia
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
5/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Aortic valve incompetence
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Angina pectoris
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.9%
4/138 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.0%
7/692 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Cardiac disorders
Acute coronary syndrome
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Thrombocytopenia
6.5%
9/138 • Number of events 12 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
7.2%
10/138 • Number of events 13 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
7.1%
49/692 • Number of events 75 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Pancytopenia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Neutropenia
34.8%
48/138 • Number of events 134 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
37.0%
51/138 • Number of events 173 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
32.7%
226/692 • Number of events 604 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Microcytosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Lymphopenia
2.9%
4/138 • Number of events 13 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.3%
16/692 • Number of events 34 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Lymphocytosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Lymphadenopathy
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Lymph node pain
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Leukopenia
10.1%
14/138 • Number of events 47 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
6.5%
9/138 • Number of events 18 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
7.5%
52/692 • Number of events 126 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Leukocytosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Iron deficiency anaemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Hypoglobulinaemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Hypochromic anaemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Haematotoxicity
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Febrile neutropenia
2.2%
3/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 8 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
2.2%
15/692 • Number of events 22 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Eosinophilia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Coagulopathy
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Anaemia
16.7%
23/138 • Number of events 35 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
15.2%
21/138 • Number of events 32 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
15.3%
106/692 • Number of events 172 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Blood and lymphatic system disorders
Agranulocytosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Endocrine disorders
Hypothyroidism
1.4%
2/138 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
1.4%
2/138 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 5 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Endocrine disorders
Autoimmune thyroiditis
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Endocrine disorders
Goitre
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Endocrine disorders
Hypoaldosteronism
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Endocrine disorders
Thyroid disorder
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Endocrine disorders
Thyroid mass
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Endocrine disorders
Thyroiditis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Hepatobiliary disorders
Biliary colic
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Hepatobiliary disorders
Chloangitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Hepatobiliary disorders
Choleithiasis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Hepatobiliary disorders
Hepatocellular injury
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 6 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Hepatobiliary disorders
Hepatotoxicity
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.43%
3/692 • Number of events 3 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Hepatobiliary disorders
Liver disorder
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Product Issues
Device occlusion
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Product Issues
Thrombosis in device
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Congenital, familial and genetic disorders
Porokeratosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Endocrine disorders
Hyperthyroidism
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.58%
4/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Endocrine disorders
Inappropriate antidiuretic hormone secretion
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Hepatobiliary disorders
Cholestasis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 4 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Hepatobiliary disorders
Cholecystitis chronic
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Hepatobiliary disorders
Hepatic cyst
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Hepatobiliary disorders
Hepatic function abnormal
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Hepatobiliary disorders
Hepatic lesion
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Hepatobiliary disorders
Hepatic steatosis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Congenital, familial and genetic disorders
Thyroglossal cyst
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Prostatic disorder
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.29%
2/692 • Number of events 2 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Breast mass
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Genital rash
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Menometrorrhagia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Menorrhagia
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Prostatitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Spermatic cord mass
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Spermatic cord pain
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Testicular swelling
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Reproductive system and breast disorders
Vulvovaginal inflammation
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Cancer surgery
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Vascular operation
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Surgical and medical procedures
Wisdom teeth removal
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
0.00%
0/138 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.72%
1/138 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.
0.14%
1/692 • Number of events 1 • From Baseline up to 47 months
The SAF population included all participants who had received at least one dose of rituximab during the study (Induction, Maint I, Maint II) and were assigned to treatment groups. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 were collected for this arm, therefore arms are not comparable overall. All AEs reported in Arm A and Arm B are also included in All Participants.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Results disclosure agreements

  • Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
  • Publication restrictions are in place

Restriction type: OTHER