Comparison · NCT01080391-sae
Lenalidomide and Dexamethasone (Rd) vs Carfilzomib, Lenalidomide, and Dexamethasone (CRd): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Lenalidomide and Dexamethasone (Rd) vs Carfilzomib, Lenalidomide, and Dexamethasone (CRd): serious adverse events. Trial comparisons, record NCT01080391-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01080391-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 | 0.568 | 0.518 | 0.616 | wilson | |
| Risk in group 2 | 0.653 | 0.605 | 0.698 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0849 | -0.152 | -0.0165 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.87 | 0.777 | 0.974 | log | |
| Odds ratio, group 1 over group 2 | 0.699 | 0.523 | 0.933 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Lenalidomide and Dexamethasone (Rd) than on Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | 11.8 | 6.57 | 60.4 | 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 | Lenalidomide and Dexamethasone (Rd) | Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22. | 221 | 389 | EG000 |
| Group 2 | Carfilzomib, Lenalidomide, and Dexamethasone (CRd) | Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle. | 256 | 392 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Source ClinicalTrials.gov
Trial
- Title
- Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma
- NCT number
- NCT01080391
- Phases
- PHASE3
- Conditions
- Relapsed Multiple Myeloma
- Interventions
- Dexamethasone, Lenalidomide, Carfilzomib
- Lead sponsor
- Amgen
- Results first posted
- 2015-07-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01080391?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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