Comparison · NCT00376961-sae
Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction vs Bortezomib Maintenance (VM): 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-CHOP-Bortezomib (R-CHOP-V) Induction vs Bortezomib Maintenance (VM): serious adverse events. Trial comparisons, record NCT00376961-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00376961-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 | 0.0154 | 0.00272 | 0.0821 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0756 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0154 | -0.0612 | 0.0821 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm, for one more participant with a serious adverse event on Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction than on Bortezomib Maintenance (VM) | 65 | 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-CHOP-Bortezomib (R-CHOP-V) Induction | Rituximab-CHOP-Bortezomib (R-CHOP-V) induction is administered every 21 days for 6 cycles (1 cycle= 21 days) | 1 | 65 | EG000 |
| Group 2 | Bortezomib Maintenance (VM) | Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months) | 0 | 47 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Assessed prior to each cycle (for Cycles 2-6), at restaging (between Cycle 6 and 7), every 3 months ( for Cycle 7-14), and at the end of protocol treatment.
Source ClinicalTrials.gov
Trial
- Title
- S0601 Rituximab, Combination Chemotherapy, and Bortezomib Followed by Bortezomib Alone in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
- NCT number
- NCT00376961
- Phases
- PHASE2
- Conditions
- Lymphoma
- Interventions
- rituximab, bortezomib, cyclophosphamide, doxorubicin hydrochloride, prednisone, vincristine sulfate
- Lead sponsor
- SWOG Cancer Research Network
- Results first posted
- 2013-02-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00376961?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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