Comparison · NCT01056510-sae
Rituximab + Bendamustine vs Rituximab + Chlorambucil: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Rituximab + Bendamustine vs Rituximab + Chlorambucil: serious adverse events. Trial comparisons, record NCT01056510-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01056510-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.412 | 0.343 | 0.486 | wilson | |
| Risk in group 2 | 0.315 | 0.251 | 0.386 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0978 | -0.00219 | 0.195 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.31 | 0.992 | 1.73 | log | |
| Odds ratio, group 1 over group 2 | 1.53 | 0.989 | 2.36 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Rituximab + Bendamustine than on Rituximab + Chlorambucil | 10.2 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Rituximab + Bendamustine | Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m\^2 on Day 1 of Cycle 1 and 500 mg/m\^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m\^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m\^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD. | 73 | 177 | EG000 |
| Group 2 | Rituximab + Chlorambucil | Participants received IV rituximab 375 mg/m\^2 on Day 1 of Cycle 1 and 500 mg/m\^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m\^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD. | 56 | 178 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From Baseline up to 8 weeks after the start of the last treatment cycle (nonserious adverse events [AEs]; up to 56 weeks) or until the EOT visit (serious AEs; up to 4.5 years)
Source ClinicalTrials.gov
Trial
- Title
- A Study of MabThera Added to Bendamustine or Chlorambucil in Patients With Chronic Lymphocytic Leukemia (MaBLe)
- NCT number
- NCT01056510
- Phases
- PHASE4
- Conditions
- Lymphocytic Leukemia, Chronic
- Interventions
- bendamustine, chlorambucil, rituximab [MabThera/Rituxan]
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2015-06-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01056510?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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