Comparison · NCT00312845-sae
Bortezomib + Rituximab vs 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. Bortezomib + Rituximab vs Rituximab: serious adverse events. Trial comparisons, record NCT00312845-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00312845-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 | 0.177 | 0.139 | 0.221 | wilson | |
| Risk in group 2 | 0.109 | 0.0802 | 0.147 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0675 | 0.0146 | 0.121 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.62 | 1.1 | 2.37 | log | |
| Odds ratio, group 1 over group 2 | 1.75 | 1.13 | 2.73 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Bortezomib + Rituximab than on Rituximab | 14.8 | 8.29 | 68.6 | 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 | Bortezomib + Rituximab | 1.6 mg/m\^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m\^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m\^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab). | 59 | 334 | EG000 |
| Group 2 | Rituximab | 375 mg/m\^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m\^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses). | 37 | 339 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- the end of study
Source ClinicalTrials.gov
Trial
- Title
- Study of VELCADE and Rituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
- NCT number
- NCT00312845
- Phases
- PHASE3
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- Bortezomib + Rituximab, Rituximab
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Results first posted
- 2011-07-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00312845?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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