Comparison · NCT01450761-sae
10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE vs PLACEBO + PLATINUM/ETOPOSIDE: 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. 10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE vs PLACEBO + PLATINUM/ETOPOSIDE: serious adverse events. Trial comparisons, record NCT01450761-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01450761-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 | 0.562 | 0.521 | 0.603 | wilson | |
| Risk in group 2 | 0.496 | 0.454 | 0.537 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0667 | 0.00835 | 0.124 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.13 | 1.02 | 1.27 | log | |
| Odds ratio, group 1 over group 2 | 1.31 | 1.03 | 1.65 | log | |
| Number needed to harm, for one more participant with a serious adverse event on 10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE than on PLACEBO + PLATINUM/ETOPOSIDE | 15 | 8.03 | 120 | 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 | 10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE | 316 | 562 | EG000 | |
| Group 2 | PLACEBO + PLATINUM/ETOPOSIDE | 278 | 561 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose to last dose plus 90 days, up to a maximum of 3 years. Assessed through study completion (May 2017).
Source ClinicalTrials.gov
Trial
- Title
- Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone
- NCT number
- NCT01450761
- Phases
- PHASE3
- Conditions
- Small Cell Lung Carcinoma
- Interventions
- Ipilimumab, Placebo matching Ipilimumab, Etoposide, Cisplatin, Carboplatin
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2016-07-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01450761?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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