{"analyses":[{"ciLowerLimit":"0.724","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.016","estimateComment":"The HR and CI were estimated from a stratified Cox proportional hazards model adjusting for PD-L1 (TC ≥50% vs \\<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using Efron method to control for ties.","groupDescription":"D + SoC vs SoC alone. An HR \\<1 favors D + SoC to be associated with a longer OS than SoC alone.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.07581","pValueComment":"Analysis was performed using a stratified log-rank test adjusting for PD-L1 tumor expression (TC ≥50% vs \\<50%), histology (squamous vs non-squamous) and disease stage (IVA vs IVB) and using the Breslow approach for handling ties.","paramType":"Hazard Ratio (HR)","paramValue":"0.86","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.4","upperLimit":"14.7","value":"13.3"},{"groupId":"OG001","lowerLimit":"10.5","upperLimit":"13.1","value":"11.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"338"},{"groupId":"OG001","value":"337"}],"units":"Participants"}],"description":"OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The final analysis of OS in the global cohort was pre-specified after approximately 532 OS events occurred across the D + SoC and SoC alone treatment arms (80% maturity).","dispersionType":"95% Confidence Interval","groups":[{"description":"During chemotherapy (combination) stage:\n\nPatients received durvalumab 1500 mg monotherapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).\n\nThe SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).\n\nPost-chemotherapy (maintenance) stage:\n\nPatients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.\n\nNon-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator.","id":"OG000","title":"D + SoC"},{"description":"During chemotherapy (combination) stage:\n\nPatients received SoC chemotherapy alone via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Patients could also receive SoC chemotherapy for an additional 2 cycles Q3W on Weeks 12 and 15 if clinically indicated and at the Investigator's discretion before the patient entered follow-up.\n\nThe SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).\n\nPost-chemotherapy (maintenance) stage:\n\nNon-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q3W or Q4W (dependent on Investigator decision and local standards) from Week 12 until PD, unless contraindicated per the Investigator.","id":"OG001","title":"SoC Alone"}],"paramType":"MEDIAN","populationDescription":"Global cohort: The FAS included all randomized patients. Analysis of OS was assessed as a primary outcome measure for comparison of the D + SoC vs SoC alone treatment arms only. The alternative treatment arm comparisons were assessed as a secondary outcome measure.","reportingStatus":"POSTED","timeFrame":"From baseline until death due to any cause. Assessed until global cohort DCO of 12 March 2021 (maximum of approximately 45 months).","title":"Overall Survival (OS); D + SoC Compared With SoC Alone","type":"PRIMARY","unitOfMeasure":"months"}