{"analyses":[{"ciLowerLimit":"0.625","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.910","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 + EP vs EP. HR \\<1 favors D + EP to be associated with a longer OS than EP.","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0032","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":"0.75","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.682","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.995","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 EP. The alpha level applied at the global cohort final analysis was adjusted (using a generalized Haybittle-Peto method) to account for actual alpha spent at the interim analysis based on the actual final total number of events, and thus maintain control of overall Type I error. Boundary for declaring statistical significance was 0.0418 for a 5% overall alpha.\n\nHR \\<1 favors D + T + EP to be associated with a longer OS than EP.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0451","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":"0.82","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"},{"groupId":"OG002","lowerLimit":"9.3","upperLimit":"11.2","value":"10.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"268"},{"groupId":"OG001","value":"268"},{"groupId":"OG002","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. This primary outcome measure presents OS for the analysis of D + EP vs EP and D + T + EP vs EP at the time of the global cohort final analysis DCO (27 January 2020). Analysis of D + EP vs EP at the global cohort interim analysis DCO is presented in the previous primary outcome measure. Analysis of D + T + EP vs D + EP (global cohort final analysis) is presented as a secondary outcome measure.","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"},{"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":"OG002","title":"Global Cohort: 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; Assessed at Global Cohort Final Analysis; D + EP Compared With EP and D + T + EP Compared With EP","type":"PRIMARY","unitOfMeasure":"months"}