Comparison · NCT00433537-sae
Step 1 - VcR-CVAD Induction vs Step 2 - Maintenance Rituximab: 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. Step 1 - VcR-CVAD Induction vs Step 2 - Maintenance Rituximab: serious adverse events. Trial comparisons, record NCT00433537-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00433537-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 | 0.935 | 0.857 | 0.972 | wilson | |
| Risk in group 2 | 0.356 | 0.232 | 0.502 | wilson | |
| Risk difference, group 1 minus group 2 | 0.58 | 0.414 | 0.708 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.63 | 1.77 | 3.91 | log | |
| Odds ratio, group 1 over group 2 | 26.1 | 8.75 | 77.8 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Step 1 - VcR-CVAD Induction than on Step 2 - Maintenance Rituximab | 1.73 | 1.41 | 2.42 | from the risk difference interval |
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 | Step 1 - VcR-CVAD Induction | All patients who received VcR-CVAD induction. | 72 | 77 | EG000 |
| Group 2 | Step 2 - Maintenance Rituximab | All patients who received maintenance rituximab. | 16 | 45 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Source ClinicalTrials.gov
Trial
- Title
- Combination Chemotherapy and Rituximab in Treating Patients With Untreated Mantle Cell Lymphoma
- NCT number
- NCT00433537
- Phases
- PHASE2
- Conditions
- Contiguous Stage II Mantle Cell Lymphoma, Noncontiguous Stage II Mantle Cell Lymphoma, Stage I Mantle Cell Lymphoma, Stage III Mantle Cell Lymphoma, Stage IV Mantle Cell Lymphoma
- Interventions
- bortezomib, rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, dexamethasone, filgrastim, pegfilgrastim, Autologous stem cell transplantation (ASCT)
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2014-10-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00433537?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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