Comparison · NCT00103506-23313a3a
Velcade (Bortezomib) Monotherapy vs Doxil/Caelyx Plus Velcade (Bortezomib): Number of Participants With Serious Adverse Events (SAEs)
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): Number of Participants With Serious Adverse Events (SAEs). Trial comparisons, record NCT00103506-23313a3a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00103506-23313a3a
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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 the outcome 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 | OG000 |
| 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 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Serious Adverse Events (SAEs)
- Description
A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
- Time frame
- Up to 1 year and 11 months (From date of first participant randomization [20 December 2004] to cut-off date for safety update (28 November 2006)
- Population
Safety population included all the participants who received at least one dose of study drug. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
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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