Comparison · NCT00103506-sae
Velcade (Bortezomib) Monotherapy vs Doxil/Caelyx Plus Velcade (Bortezomib): 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. Velcade (Bortezomib) Monotherapy vs Doxil/Caelyx Plus Velcade (Bortezomib): serious adverse events. Trial comparisons, record NCT00103506-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00103506-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 | 0.33 | 0.281 | 0.384 | wilson | |
| Risk in group 2 | 0.377 | 0.326 | 0.432 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0472 | -0.121 | 0.0271 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.875 | 0.709 | 1.08 | log | |
| Odds ratio, group 1 over group 2 | 0.813 | 0.587 | 1.13 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Velcade (Bortezomib) Monotherapy than on Doxil/Caelyx Plus Velcade (Bortezomib) | 21.2 | 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 | Velcade (Bortezomib) Monotherapy | Velcade (bortezomib) 1.3 milligram/meter per square (mg/m\^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. | 105 | 318 | EG000 |
| Group 2 | Doxil/Caelyx Plus Velcade (Bortezomib) | Velcade (bortezomib) 1.3 mg/m\^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m\^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles. | 120 | 318 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Study of DOXIL/CAELYX (Pegylated Liposomal Doxorubicin) and VELCADE (Bortezomib) or VELCADE Monotherapy for the Treatment of Relapsed Multiple Myeloma
- NCT number
- NCT00103506
- Phases
- PHASE3
- Conditions
- Multiple Myeloma
- Interventions
- Bortezomib (VELCADE), Bortezomib (VELCADE), Doxorubicin hydrochloride (DOXIL/CAELYX)
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2015-05-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00103506?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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