{"analyses":[{"ciLowerLimit":"0.890","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.309","estimateComment":"The HR and 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 + T + EP vs D + EP. HR \\<1 favors D + T + EP to be associated with a longer OS than D + EP.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.4352","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":"1.08","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.6","upperLimit":"12.0","value":"10.4"},{"groupId":"OG001","lowerLimit":"11.3","upperLimit":"14.7","value":"12.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"268"},{"groupId":"OG001","value":"268"}],"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. This secondary outcome measure presents OS for the analysis of D + T + EP vs D + EP in the global cohort. The alternative treatment comparisons in the global cohort were performed as primary outcome measures.","dispersionType":"95% Confidence Interval","groups":[{"description":"During Chemotherapy:\n\nPatients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 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. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.","id":"OG000","title":"Global Cohort: D + T + EP"},{"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":"OG001","title":"Global Cohort: D + EP"}],"paramType":"MEDIAN","populationDescription":"The global FAS included all patients randomized prior to the end of global recruitment.","reportingStatus":"POSTED","timeFrame":"From baseline until death due to any cause. Assessed until global cohort final analysis DCO (maximum of approximately 33 months).","title":"OS in the Global Cohort; D + T + EP Compared With D + EP","type":"SECONDARY","unitOfMeasure":"months"}