Comparison · NCT00634179-sae
Phase I: Induction vs Phase II: Maintenance: 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. Phase I: Induction vs Phase II: Maintenance: serious adverse events. Trial comparisons, record NCT00634179-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00634179-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 | 0.158 | 0.0552 | 0.376 | wilson | |
| Risk in group 2 | 0.0345 | 0.00611 | 0.172 | wilson | |
| Risk difference, group 1 minus group 2 | 0.123 | -0.048 | 0.343 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 4.58 | 0.513 | 40.8 | log | |
| Odds ratio, group 1 over group 2 | 5.25 | 0.503 | 54.8 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Phase I: Induction than on Phase II: Maintenance | 8.1 | 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 | Phase I: Induction | Phase I will identify the maximal tolerated doses of bortezomib and vincristine when used in a combination of bortezomib, rituximab and the CHOP chemotherapy regimen. | 3 | 19 | EG000 |
| Group 2 | Phase II: Maintenance | In Phase II, the trial will evaluate the efficacy and safety of the MTD combination of VELCADE and rituximab-CHOP in additional subjects who have untreated follicular B-NHL. (Grade 1, 2, 3a), small lymphocytic lymphoma, or marginal zone lymphoma. | 1 | 29 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- A Phase I/II Trial of VR-CHOP in Lymphoma Patients
- NCT number
- NCT00634179
- Phases
- PHASE1, PHASE2
- Conditions
- Lymphoma, B-Cell, Follicular Lymphoma
- Interventions
- Bortezomib, Rituximab, Doxorubicin, Cyclophosphamide, Vincristine, Prednisone
- Lead sponsor
- Emory University
- Results first posted
- 2016-03-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00634179?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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