Comparison · NCT02252172-sae
Lenalidomide + Dexamethasone (Rd) vs Daratumumab + Lenalidomide + Dexamethasone (DRd): 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. Lenalidomide + Dexamethasone (Rd) vs Daratumumab + Lenalidomide + Dexamethasone (DRd): serious adverse events. Trial comparisons, record NCT02252172-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02252172-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 | 0.718 | 0.67 | 0.762 | wilson | |
| Risk in group 2 | 0.794 | 0.749 | 0.832 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0761 | -0.138 | -0.0138 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.904 | 0.832 | 0.982 | log | |
| Odds ratio, group 1 over group 2 | 0.66 | 0.469 | 0.929 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Lenalidomide + Dexamethasone (Rd) than on Daratumumab + Lenalidomide + Dexamethasone (DRd) | 13.1 | 7.26 | 72.7 | 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 + Dexamethasone (Rd) | Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group \[IMWG\] criteria). | 262 | 365 | EG000 |
| Group 2 | Daratumumab + Lenalidomide + Dexamethasone (DRd) | Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity up to 77.3 months. After implementation of Amendment 8, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab subcutaneous (SC) injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria). | 289 | 364 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- All-cause mortality: From randomization (Day -3) up to 8.7 years; Serious and Other AEs: From start of treatment (Day 1) up to 6.6 years
Source ClinicalTrials.gov
Trial
- Title
- Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma
- NCT number
- NCT02252172
- Phases
- PHASE3
- Conditions
- Multiple Myeloma
- Interventions
- Daratumumab IV, Lenalidomide, Dexamethasone, Daratumumab SC
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2020-01-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02252172?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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