Comparison · NCT01818752-sae
Bortezomib, Melphalan, Prednisone vs Carfilzomib, Melphalan, Prednisone: 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. Bortezomib, Melphalan, Prednisone vs Carfilzomib, Melphalan, Prednisone: serious adverse events. Trial comparisons, record NCT01818752-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01818752-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 | 0.421 | 0.377 | 0.466 | wilson | |
| Risk in group 2 | 0.496 | 0.451 | 0.541 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0745 | -0.137 | -0.0109 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.85 | 0.739 | 0.977 | log | |
| Odds ratio, group 1 over group 2 | 0.74 | 0.573 | 0.957 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Bortezomib, Melphalan, Prednisone than on Carfilzomib, Melphalan, Prednisone | 13.4 | 7.29 | 91.4 | 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, Melphalan, Prednisone | Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m². | 198 | 470 | EG000 |
| Group 2 | Carfilzomib, Melphalan, Prednisone | Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m². | 235 | 474 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups.
Source ClinicalTrials.gov
Trial
- Title
- Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma
- NCT number
- NCT01818752
- Phases
- PHASE3
- Conditions
- Multiple Myeloma
- Interventions
- Carfilzomib, Bortezomib, Melphalan, Prednisone
- Lead sponsor
- Amgen
- Results first posted
- 2017-08-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01818752?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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