Comparison · NCT00310037-sae
Arm A Maintenance Therapy vs Arm B Consolidation Therapy: 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. Arm A Maintenance Therapy vs Arm B Consolidation Therapy: serious adverse events. Trial comparisons, record NCT00310037-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00310037-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 | 0.25 | 0.152 | 0.382 | wilson | |
| Risk in group 2 | 0.2 | 0.112 | 0.33 | wilson | |
| Risk difference, group 1 minus group 2 | 0.05 | -0.113 | 0.208 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.25 | 0.604 | 2.59 | log | |
| Odds ratio, group 1 over group 2 | 1.33 | 0.523 | 3.4 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Arm A Maintenance Therapy than on Arm B Consolidation Therapy | 20 | 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 | Arm A Maintenance Therapy | Patients receive bortezomib 1.6 mg/m\^2 IV on days 1, 8, 15, and 22 once daily for 4 weeks. There will be a 4 week rest period. One cycle is a total of 8 weeks. A total of 10 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity. | 13 | 52 | EG000 |
| Group 2 | Arm B Consolidation Therapy | Patients receive bortezomib 1.3 mg/m\^2 IV on days 1, 4, 8, and 11 once daily for 3 weeks. One cycle is a total of 3 weeks. A total of 4 cycles of bortezomib will be given in the absence of disease progression or unacceptable toxicity. | 10 | 50 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Bortezomib After Combination Chemotherapy, Rituximab, and an Autologous Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma
- NCT number
- NCT00310037
- Phases
- PHASE2
- Conditions
- Mantle Cell Lymphoma
- Interventions
- bortezomib
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Results first posted
- 2018-07-31
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00310037?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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