{"analyses":[{"ciLowerLimit":"0.64","ciNumSides":"TWO_SIDED","ciPctValue":"97","ciUpperLimit":"0.99","estimateComment":"The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for disease status and primary tumor location.","groupDescription":"The 2-sided significance level for OS at the second interim analysis was 3%.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","otherAnalysisDescription":"95% CI 0.66 to 0.97","pValue":"0.021","pValueComment":"The analysis was performed using a stratified log-rank test adjusting for disease status (initially unresectable versus recurrent) and primary tumor location (IHCC versus EHCC versus GBC), and tested at 0.03 significance level.","paramType":"Hazard Ratio (HR)","paramValue":"0.80","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.1","upperLimit":"14.0","value":"12.8"},{"groupId":"OG001","lowerLimit":"10.1","upperLimit":"12.5","value":"11.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"344"}],"units":"Participants"}],"description":"Overall Survival (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. The second interim analysis was pre-specified after approximately 397 OS events occurred in both arms (59% maturity).","dispersionType":"95% Confidence Interval","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":"MEDIAN","populationDescription":"Full analysis set","reportingStatus":"POSTED","timeFrame":"From date of randomization until death due to any cause. Assessed up to maximum of approximately 27 months (from date of randomization to primary analysis data cut-off)","title":"Overall Survival (OS)","type":"PRIMARY","unitOfMeasure":"Months"}