Comparison · NCT00877006-sae
Bendamustine and Rituximab (BR) vs R-CHOP/CVP: 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. Bendamustine and Rituximab (BR) vs R-CHOP/CVP: serious adverse events. Trial comparisons, record NCT00877006-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00877006-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 | 0.271 | 0.217 | 0.334 | wilson | |
| Risk in group 2 | 0.228 | 0.177 | 0.288 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0436 | -0.0378 | 0.124 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.19 | 0.859 | 1.65 | log | |
| Odds ratio, group 1 over group 2 | 1.26 | 0.817 | 1.95 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Bendamustine and Rituximab (BR) than on R-CHOP/CVP | 22.9 | 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 | Bendamustine and Rituximab (BR) | Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m\^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m\^2 IV on Day 1. | 60 | 221 | EG000 |
| Group 2 | R-CHOP/CVP | Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m\^2 IV on Day 1; vincristine 1.4 mg/m\^2 (up to 2 mg/m\^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m\^2 IV Day 1; cyclophosphamide 750 mg/m\^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m\^2 IV on Day 1; cyclophosphamide 750 mg/m\^2 IV on Day 1 or cyclophosphamide 1000 mg/m\^2 IV on Day 1; vincristine 1.4 mg/m\^2 (up to 2 mg/m\^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5 | 49 | 215 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Treatment Period: 32 weeks No adverse event data was collected during the 5-year Long-Term Follow-Up Period
Source ClinicalTrials.gov
Trial
- Title
Study of Bendamustine Hydrochloride and Rituximab (BR) Compared With R-CVP or R-CHOP in the First-Line Treatment of Patients With Advanced Indolent Non-Hodgkin's Lymphoma (NHL) or Mantle Cell Lymphoma (MCL) - Referred to as the BRIGHT Study
- NCT number
- NCT00877006
- Phases
- PHASE3
- Conditions
- Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma
- Interventions
- bendamustine, rituximab, vincristine, prednisone, cyclophosphamide, doxorubicin
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Results first posted
- 2014-04-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00877006?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.
For software
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