Comparison · NCT00312845-ce6e2a5d
Bortezomib + Rituximab vs Rituximab: Overall Response Rate
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: Overall Response Rate. Trial comparisons, record NCT00312845-ce6e2a5d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00312845-ce6e2a5d
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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 | 0.632 | 0.577 | 0.683 | wilson | |
| Risk in group 2 | 0.494 | 0.44 | 0.548 | wilson | |
| Risk difference, group 1 minus group 2 | 0.138 | 0.061 | 0.212 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.28 | 1.11 | 1.47 | log | |
| Odds ratio, group 1 over group 2 | 1.76 | 1.28 | 2.41 | log | |
| Number needed to treat, for one more participant with the outcome on Bortezomib + Rituximab than on Rituximab | 7.25 | 4.71 | 16.4 | 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). | 199 | 315 | OG000 |
| 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). | 160 | 324 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Overall Response Rate
- Description
Overall response rate is defined as Complete Response (CR) + Complete Response Unconfirmed (CRu) + Partial Response (PR) using International Working Group Criteria (IWGC) and Independent Radiographic Review results and clinical results. The IWGC CR requires complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms, and normalization of lactic dehydrogenase and bone marrow involvement. CRu requires more than 75% reduction in sum of product of nodes (SPD). PR requires moer than 50% reduction in SPD.
- Time frame
- Subjects are followed until progressive disease/death or the end of the study. The median follow up time is 33.9 months.
- Population
The response-evaluable population was defined as all subjects in the ITT population who received at least 1 dose of VELCADE or rituximab, had at least 1 measurable tumor mass (\>1.5 cm in the longest dimension and \>1.0 cm in the short axis) at baseline, and had at least 1 post-baseline disease assessment by independent radiology reviewers/IRC.
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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