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Comparison · NCT01285609-deaths

10 MG/KG Ipilimumab + Paclitaxel/ Carbop vs Placebo + Paclitaxel/ Carboplatin: deaths from any cause

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: deaths from any cause. Trial comparisons, record NCT01285609-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01285609-deaths

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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 10.7560.7150.792wilson
Risk in group 20.7840.7450.819wilson
Risk difference, group 1 minus group 2-0.0286-0.0820.025newcombe hybrid score
Risk ratio, group 1 over group 20.9640.8991.03log
Odds ratio, group 1 over group 20.8510.6281.15log
Number needed to treat, for one fewer death from any cause on 10 MG/KG Ipilimumab + Paclitaxel/ Carbop than on Placebo + Paclitaxel/ Carboplatin35from the risk difference intervalthe interval includes no difference

Groups2

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

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 110 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
359475EG000
Group 2Placebo + 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
371473EG001

Harm

What it counts
Total, all-cause mortality
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

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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