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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

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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.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.7180.670.762wilson
Risk in group 20.7940.7490.832wilson
Risk difference, group 1 minus group 2-0.0761-0.138-0.0138newcombe hybrid score
Risk ratio, group 1 over group 20.9040.8320.982log
Odds ratio, group 1 over group 20.660.4690.929log
Number needed to treat, for one fewer participant with a serious adverse event on Lenalidomide + Dexamethasone (Rd) than on Daratumumab + Lenalidomide + Dexamethasone (DRd)13.17.2672.7from the risk difference interval

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Lenalidomide + 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).
262365EG000
Group 2Daratumumab + 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).
289364EG001

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

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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