{"analyses":[{"ciLowerLimit":"1.086","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.401","groupDescription":"D + EP vs EP. An odds ratio \\>1 favors D + EP.","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0177","pValueComment":"Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.","paramType":"Odds Ratio (OR)","paramValue":"1.61","statisticalMethod":"Regression, Logistic"},{"ciLowerLimit":"0.817","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.746","groupDescription":"D + T + EP vs EP. An odds ratio \\>1 favors D + T + EP.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.3611","pValueComment":"Analysis was performed using a logistic regression model, adjusting for planned platinum therapy in Cycle 1 (carboplatin or cisplatin). P-value is based on twice the change in log-likelihood resulting from addition of a treatment factor to the model.","paramType":"Odds Ratio (OR)","paramValue":"1.19","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"74.2"},{"groupId":"OG001","value":"79.5"},{"groupId":"OG002","value":"70.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"267"},{"groupId":"OG001","value":"268"},{"groupId":"OG002","value":"269"}],"units":"Participants"}],"description":"ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of patients with at least 1 visit response of Complete Response (CR) or Partial Response (PR). CR was defined as disappearance of all TLs since baseline (any pathological lymph nodes selected as TLs must have a reduction in short axis diameter to \\<10 mm) or disappearance of all NTLs since baseline (all lymph nodes must be non-pathological in size \\[\\<10 mm short axis\\]). PR was defined as at least a 30% decrease in the sum of diameters of TLs (taking as reference the baseline sum of diameters).","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":"NUMBER","populationDescription":"The global FAS included all patients randomized prior to the end of global recruitment. The denominator was a subset of the FAS population who had measurable disease at baseline.","reportingStatus":"POSTED","timeFrame":"Tumour scans performed at baseline, Week 6, Week 12 then every 8 weeks relative to the date of randomization until RECIST 1.1-defined progression. Assessed until global cohort final analysis DCO (maximum of approximately 33 months).","title":"Objective Response Rate (ORR) in the Global Cohort","type":"SECONDARY","unitOfMeasure":"percentage of patients"}