Comparison · NCT01335399-sae
E-Ld Cohort vs Ld Cohort: 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. E-Ld Cohort vs Ld Cohort: serious adverse events. Trial comparisons, record NCT01335399-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01335399-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 | 0.79 | 0.745 | 0.828 | wilson | |
| Risk in group 2 | 0.752 | 0.706 | 0.793 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0377 | -0.0228 | 0.0979 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.05 | 0.971 | 1.14 | log | |
| Odds ratio, group 1 over group 2 | 1.24 | 0.879 | 1.75 | log | |
| Number needed to harm, for one more participant with a serious adverse event on E-Ld Cohort than on Ld Cohort | 26.5 | 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 | E-Ld Cohort | Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | 293 | 371 | EG000 |
| Group 2 | Ld Cohort | Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle | 279 | 371 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
All-cause mortality: from first patient first visit to study completion: approximately up to 10 years and 1 month. Serious and non serious AEs: From first dose to 60 days after last dose (on average 34 months up to approximately 113 months)
Source ClinicalTrials.gov
Trial
- Title
- Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma
- NCT number
- NCT01335399
- Phases
- PHASE3
- Conditions
- Multiple Myeloma
- Interventions
- Lenalidomide, Dexamethasone, Dexamethasone, Dexamethasone, Dexamethasone, Elotuzumab (BMS-901608; HuLuc63), Elotuzumab (BMS-901608; HuLuc63)
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2020-10-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01335399?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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