Comparison · NCT01285609-sae
10 MG/KG Ipilimumab + Paclitaxel/ Carbop vs Placebo + Paclitaxel/ Carboplatin: 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. 10 MG/KG Ipilimumab + Paclitaxel/ Carbop vs Placebo + Paclitaxel/ Carboplatin: serious adverse events. Trial comparisons, record NCT01285609-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01285609-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 | 0.632 | 0.587 | 0.674 | wilson | |
| Risk in group 2 | 0.497 | 0.452 | 0.542 | wilson | |
| Risk difference, group 1 minus group 2 | 0.135 | 0.0717 | 0.196 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.27 | 1.13 | 1.42 | log | |
| Odds ratio, group 1 over group 2 | 1.74 | 1.34 | 2.25 | log | |
| Number needed to harm, for one more participant with a serious adverse event on 10 MG/KG Ipilimumab + Paclitaxel/ Carbop than on Placebo + Paclitaxel/ Carboplatin | 7.42 | 5.09 | 13.9 | 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 + Paclitaxel/ Carbop | Ipilimumab + Active Chemotherapy Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemo Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses | 300 | 475 | EG000 |
| Group 2 | Placebo + Paclitaxel/ Carboplatin | Placebo + Active Chemotherapy Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin). Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Active Chemotherapy Backbone: Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses | 235 | 473 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day of first dose to 90 days post final dose, up to August 2017 (approximately 72 months post study start)
Source ClinicalTrials.gov
Trial
- Title
- Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin
- NCT number
- NCT01285609
- Phases
- PHASE3
- Conditions
- Lung Cancer - Non Small Cell Squamous
- Interventions
- Ipilimumab, Placebo, Paclitaxel, Carboplatin
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2016-06-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01285609?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.
For software
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GET https://conductscience.org/api/comparisons/v1/NCT01285609-sae