{"analyses":[{"ciLowerLimit":"0.63","ciNumSides":"TWO_SIDED","ciPctValue":"95.19","ciUpperLimit":"0.89","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 PFS at the second interim analysis was 4.81%.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","otherAnalysisDescription":"95% CI 0.63 to 0.89","pValue":"0.001","pValueComment":"The p-value is based on 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 0.0481 significance level.","paramType":"Hazard Ratio (HR)","paramValue":"0.75","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.7","upperLimit":"7.4","value":"7.2"},{"groupId":"OG001","lowerLimit":"5.6","upperLimit":"6.7","value":"5.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"341"},{"groupId":"OG001","value":"344"}],"units":"Participants"}],"description":"PFS based on investigator assessments according to RECIST version 1.1 was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (i.e., PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of ≥5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters, or a measurable increase in a non-target lesion, or the appearance of new lesions. Median PFS was calculated using the Kaplan-Meier technique.","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":"Tumor assessments every 6 weeks after randomization for the first 24 weeks and then every 8 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death. Assessed up to maximum of approximately 27 months.","title":"Progression-free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"Months"}