Trial Outcomes & Findings for MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma. (NCT NCT00430352)
NCT ID: NCT00430352
Last Updated: 2017-08-14
Results Overview
Data presented include percentage of participants with any AE, any infusion-related AE, any serious adverse event (SAE), any infusion-related SAE (counted separately from SAEs), death, and participants with toxicity as the primary cause for treatment discontinuation.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
545 participants
Primary outcome timeframe
24 months
Results posted on
2017-08-14
Participant Flow
Participant milestones
| Measure |
Rituximab 375 Milligrams Per Square Meter (mg/m^2)
Participants received rituximab 375 mg/m\^2 intravenously (IV) once every 8 weeks for a total 12 infusions until progression, relapse, start of a new treatment, death, or toxicity.
|
|---|---|
|
Overall Study
STARTED
|
545
|
|
Overall Study
COMPLETED
|
407
|
|
Overall Study
NOT COMPLETED
|
138
|
Reasons for withdrawal
| Measure |
Rituximab 375 Milligrams Per Square Meter (mg/m^2)
Participants received rituximab 375 mg/m\^2 intravenously (IV) once every 8 weeks for a total 12 infusions until progression, relapse, start of a new treatment, death, or toxicity.
|
|---|---|
|
Overall Study
Disease progression
|
58
|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Adverse Event
|
16
|
|
Overall Study
Death
|
5
|
|
Overall Study
Other
|
48
|
Baseline Characteristics
MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.
Baseline characteristics by cohort
| Measure |
Rituximab 375 mg/m^2
n=545 Participants
Participants received rituximab 375 mg/m\^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
|
|---|---|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 11.47 • n=99 Participants
|
|
Sex: Female, Male
Female
|
313 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
232 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: Safety Population: any participant who received at least 1 dose of study treatment.
Data presented include percentage of participants with any AE, any infusion-related AE, any serious adverse event (SAE), any infusion-related SAE (counted separately from SAEs), death, and participants with toxicity as the primary cause for treatment discontinuation.
Outcome measures
| Measure |
Rituximab 375 mg/m^2
n=534 Participants
Participants received rituximab 375 mg/m\^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
|
|---|---|
|
Percentage of Participants With an Adverse Event (AE) - Overall Summary
Any AE
|
67.4 percentage of participants
|
|
Percentage of Participants With an Adverse Event (AE) - Overall Summary
Any infusion-related AE
|
5.8 percentage of participants
|
|
Percentage of Participants With an Adverse Event (AE) - Overall Summary
Any non-infusion related SAE
|
20.2 percentage of participants
|
|
Percentage of Participants With an Adverse Event (AE) - Overall Summary
Any infusion-related SAE
|
0.2 percentage of participants
|
|
Percentage of Participants With an Adverse Event (AE) - Overall Summary
Deaths
|
7.5 percentage of participants
|
|
Percentage of Participants With an Adverse Event (AE) - Overall Summary
Toxicity as primary cause for discontinuation
|
3.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dosePopulation: ITT population
PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date.
Outcome measures
| Measure |
Rituximab 375 mg/m^2
n=545 Participants
Participants received rituximab 375 mg/m\^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
|
|---|---|
|
Progression-Free Survival - Percentage of Participants With an Event
|
24.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dosePopulation: ITT population
PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date.
Outcome measures
| Measure |
Rituximab 375 mg/m^2
n=545 Participants
Participants received rituximab 375 mg/m\^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
|
|---|---|
|
Progression-Free Survival - Time to Event
|
NA months
Median and 95 percent (%) confidence interval (CI) for PFS could not be estimated due to the large number of censored participants and the short duration of follow-up.
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dosePopulation: ITT population
The percentage of participants who experienced PD or death or required a next or new lymphoma treatment over a study period of 2 years with 1 year of follow-up. EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date.
Outcome measures
| Measure |
Rituximab 375 mg/m^2
n=545 Participants
Participants received rituximab 375 mg/m\^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
|
|---|---|
|
Event-Free Survival (EFS) - Percentage of Participants With an Event
|
24.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dosePopulation: ITT population
EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date.
Outcome measures
| Measure |
Rituximab 375 mg/m^2
n=545 Participants
Participants received rituximab 375 mg/m\^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
|
|---|---|
|
Event-Free Survival (EFS) - Time to Event
|
NA months
Median and 95% CI for EFS could not be estimated due to the large number of censored participants and the short duration of follow-up.
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dosePopulation: ITT population
As a measure of overall survival (OS), the percentage of participants who died over the study period of 2 years with 1 year of follow-up. OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact.
Outcome measures
| Measure |
Rituximab 375 mg/m^2
n=545 Participants
Participants received rituximab 375 mg/m\^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
|
|---|---|
|
Overall Survival (OS) - Percentage of Participants With an Event
|
7.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dosePopulation: ITT population
OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact.
Outcome measures
| Measure |
Rituximab 375 mg/m^2
n=545 Participants
Participants received rituximab 375 mg/m\^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
|
|---|---|
|
Overall Survival (OS) - Time to Event
|
NA percentage of participants
Median and 95% CI for OS could not be estimated due to the large number of censored participants and the short duration of follow-up.
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dosePopulation: ITT population
As a measure of time to NLT (TNLT), the percentage of participants with new lymphoma treatment over a study period of 2 years with 1 year of follow-up. TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made.
Outcome measures
| Measure |
Rituximab 375 mg/m^2
n=545 Participants
Participants received rituximab 375 mg/m\^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
|
|---|---|
|
Time to Next Lymphoma Treatment (NLT) - Percentage of Participants With an Event
|
17.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dosePopulation: ITT population
TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made.
Outcome measures
| Measure |
Rituximab 375 mg/m^2
n=545 Participants
Participants received rituximab 375 mg/m\^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
|
|---|---|
|
Time to NLT - Time to Event
|
NA months
Median and 95% CI for time to NLT could not be estimated due to the large number of censored participants and the short duration of follow-up.
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dosePopulation: ITT population; only participants who received any study treatment were included in the analysis.
Percentage of participants with complete response (CR), unconfirmed CR (CRu), no change, or progressive disease (PD). For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Where possible, assessment of response was based on the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma (NHL).
Outcome measures
| Measure |
Rituximab 375 mg/m^2
n=545 Participants
Participants received rituximab 375 mg/m\^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
|
|---|---|
|
Percentage of Participants With Response by Best Response to Study Treatment
No change
|
87.5 percentage of participants
|
|
Percentage of Participants With Response by Best Response to Study Treatment
CR/CRu
|
2.1 percentage of participants
|
|
Percentage of Participants With Response by Best Response to Study Treatment
PD
|
10.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dosePopulation: ITT population; only participants with PR to most recent treatment were included in the analysis.
Percentage of participants with PR or CR(u) conversion while on rituximab maintenance therapy over a study period of 2 years with 1 year of follow-up. For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Assessment and definition of response was based on the International Workshop to Standardize Response Criteria for NHL.
Outcome measures
| Measure |
Rituximab 375 mg/m^2
n=161 Participants
Participants received rituximab 375 mg/m\^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
|
|---|---|
|
Percentage of Participants With PR Who Converted to CRu
|
6.2 percentage of participants
Interval 3.0 to 11.1
|
Adverse Events
Rituximab 375 mg/m^2
Serious events: 109 serious events
Other events: 207 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rituximab 375 mg/m^2
n=534 participants at risk
Participants received rituximab 375 mg/m\^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
|
|---|---|
|
Nervous system disorders
Cerebrovascular accident - IRR
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Infections and infestations
Pneumonia
|
1.3%
7/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Infections and infestations
Appendicitis
|
0.56%
3/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Infections and infestations
Sinusitis
|
0.37%
2/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Infections and infestations
Abdominal abscess
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Infections and infestations
Arthritis bacterial
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Infections and infestations
Aspergilloma
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Infections and infestations
Bronchiolitis
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Infections and infestations
Bronchitis
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Infections and infestations
Cellulitis
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Infections and infestations
Cerebral aspergillosis
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Infections and infestations
Diverticulitis
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Infections and infestations
Gastroenteritis
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Infections and infestations
Groin abscess
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Infections and infestations
Herpes zoster
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Infections and infestations
Meningitis enteroviral
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Infections and infestations
Otitis media
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Infections and infestations
Respiratory tract infection
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.56%
3/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Gastrointestinal disorders
Coeliac disease
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Gastrointestinal disorders
Colitis
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Gastrointestinal disorders
Food poisoning
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Gastrointestinal disorders
Gastritis
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Cardiac disorders
Coronary artery disease
|
0.37%
2/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.37%
2/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Cardiac disorders
Angina pectoris
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Cardiac disorders
Angina unstable
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Cardiac disorders
Arrhythmia
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Cardiac disorders
Cardiomyopathy
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Cardiac disorders
Myocarditis
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Cardiac disorders
Palpitation
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.37%
2/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.37%
2/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Osteosarcoma recurrent
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.56%
3/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Nervous system disorders
Dizziness
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Nervous system disorders
Epilepsy
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Nervous system disorders
Ischaemic stroke
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Nervous system disorders
Paraplegia
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Nervous system disorders
Polyneuropathy
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.56%
3/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.37%
2/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.37%
2/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.37%
2/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.37%
2/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
General disorders
Pyrexia
|
0.75%
4/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
General disorders
Chest pain
|
0.37%
2/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
General disorders
Fatigue
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
General disorders
Sudden death
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.75%
4/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.56%
3/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Hepatobiliary disorders
Biliary colic
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Hepatobiliary disorders
Cholangitis
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Hepatobiliary disorders
Liver disorder
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Surgical and medical procedures
Female sterilisation
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Surgical and medical procedures
Finger amputation
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Surgical and medical procedures
Small intestinal resection
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Eye disorders
Cataract
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Eye disorders
Eye haemorrhage
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Eye disorders
Glaucoma
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Vascular disorders
Vascular occlusion
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Psychiatric disorders
Depressed mood
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Renal and urinary disorders
Renal failure
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Social circumstances
Pregnancy of partner
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Investigations
Alanine aminotransferase increased
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Investigations
Aspartate aminotransferase increased
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.19%
1/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
Other adverse events
| Measure |
Rituximab 375 mg/m^2
n=534 participants at risk
Participants received rituximab 375 mg/m\^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.1%
38/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.8%
31/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.6%
35/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.4%
34/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
General disorders
Fatigue
|
7.5%
40/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
General disorders
Pyrexia
|
5.1%
27/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.4%
50/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Nervous system disorders
Headache
|
5.8%
31/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Vascular disorders
Hypertension
|
6.0%
32/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.9%
37/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
|
Investigations
Neutrophil count decreased
|
5.4%
29/534 • AEs were collected at up through 12 months after last dose (1 year follow-up).
AEs were collected at up through 12 months after last dose (1 year follow-up). AEs occuring within 24 hours of infusion were considered infusion-related reactions (IRRs) and were collected and reported as separate events mutually exclusive from all 'other' AEs collected and reported. These events appear in the table labeled as 'IRR'.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER