{"analyses":[{"ciLowerLimit":"0.591","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.909","estimateComment":"The HR and confidence intervals (CIs) were calculated using a stratified Cox proportional hazards model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and ties handled by Efron approach.","groupDescription":"D + EP vs EP. The global cohort interim analysis of OS was based on a Lan-DeMets alpha spending function with O'Brien Fleming type boundary, using the actual number of events observed as a proportion of the planned total. Boundary for declaring statistical significance was 0.0178 for a 4% overall alpha. Hazard Ratio (HR) \\<1 favors D + EP to be associated with a longer OS than EP.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0047","pValueComment":"Analysis was performed using the stratified log-rank test, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin), and using the rank tests of association approach.","paramType":"Hazard Ratio (HR)","paramValue":"0.73","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.5","upperLimit":"14.8","value":"13.0"},{"groupId":"OG001","lowerLimit":"9.3","upperLimit":"11.2","value":"10.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"268"},{"groupId":"OG001","value":"269"}],"units":"Participants"}],"description":"OS was defined as the time from 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. An interim analysis of OS in the global cohort was pre-specified after approximately 318 OS events occurred each between the D + EP and EP groups (60% maturity), and between the D + T + EP and EP groups (60% maturity). At the global cohort interim analysis DCO (11 March 2019), comparison of OS in the D + EP versus (vs) EP groups had crossed the pre-specified boundary. Since these results were considered final in terms of formal statistical testing, they are presented here as a primary outcome measure. Analysis of OS for D + EP vs EP and for D + T + EP vs EP at the time of the global cohort final analysis is presented separately in the subsequent primary outcome measure.","dispersionType":"95% Confidence Interval","groups":[{"description":"During Chemotherapy:\n\nPatients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).\n\nPost-Chemotherapy:\n\nPatients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.","id":"OG000","title":"Global Cohort: D + EP"},{"description":"For chemotherapy (EP), patients received etoposide (80-100 mg/m\\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.","id":"OG001","title":"Global Cohort: EP"}],"paramType":"MEDIAN","populationDescription":"The global FAS included all patients randomized prior to the end of global recruitment. Interim analysis for OS in the global cohort was performed for comparison of the D + EP vs EP groups only.","reportingStatus":"POSTED","timeFrame":"From baseline until death due to any cause. Assessed until global cohort interim analysis DCO (maximum of approximately 23 months).","title":"Overall Survival (OS) in the Global Cohort; Assessed at Global Cohort Interim Analysis; D + EP Compared With EP","type":"PRIMARY","unitOfMeasure":"months"}