{"analyses":[{"ciLowerLimit":"1.11","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.31","estimateComment":"OR and CI were estimated from a stratified CMH test adjusting for disease status and primary tumor location.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.011","paramType":"Odds Ratio (OR)","paramValue":"1.60","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"26.7"},{"groupId":"OG001","value":"18.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"343"}],"units":"Participants"}],"description":"Disease assessments based on investigator assessments were determined by using RECIST version 1.1 guidelines. The ORR was defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions. The PR was defined as \\>= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR was defined as 2 CRs or 2 PRs with no evidence of progression in-between. Patients who discontinued randomized treatment without progression, received a subsequent anti-cancer therapy and then responded were not included as responders for ORR.","groups":[{"description":"Drug: Durvalumab IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.","id":"OG000","title":"Durvalumab + Gemcitabine + Cisplatin"},{"description":"Drug: Placebo IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.","id":"OG001","title":"Placebo + Gemcitabine + Cisplatin"}],"paramType":"NUMBER","populationDescription":"Full analysis set - subjects with measurable disease at baseline","reportingStatus":"POSTED","timeFrame":"Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Assessed up to maximum of approximately 27 months.","title":"Objective Response Rate (ORR)","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}