{"analyses":[{"ciLowerLimit":"0.569","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.928","estimateComment":"Hazard ratio and CI were calculated using stratified Cox proportional hazards model, adjusting for receipt of PCI, with treatment as only covariate and ties handled by Efron approach.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.01042","paramType":"Hazard Ratio (HR)","paramValue":"0.73","statisticalComment":"The analysis was performed using the stratified log-rank test.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at the DCO.","groupId":"OG000","lowerLimit":"37.3","upperLimit":"NA","value":"55.9"},{"groupId":"OG001","lowerLimit":"25.5","upperLimit":"39.9","value":"33.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"264"},{"groupId":"OG001","value":"266"}],"units":"Participants"}],"description":"OS was defined as the time from the date of randomization until death due to any cause. Median OS was calculated using Kaplan-Meier method and its CI using Brookmeyer-Crowley method.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received durvalumab monotherapy (1500 mg for participants \\>30 kg in weight and a weight-based dosing equivalent to 20 mg/kg for participants \\<=30 kg in weight) via IV infusion once q4w, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.","id":"OG000","title":"Durvalumab"},{"description":"Participants received matching placebo via IV infusion once q4w for 4 doses/cycles each, until clinical/RECIST 1.1-defined radiological progression, intolerable toxicity, or for a maximum of 24 months, whichever occurred first.","id":"OG001","title":"Placebo"}],"paramType":"MEDIAN","populationDescription":"The FAS included all randomized participants.","reportingStatus":"POSTED","timeFrame":"From date of randomization until death due to any cause, up to DCO date 15 January 2024 (a maximum of approximately 1936 days)","title":"Durvalumab Versus Placebo: Overall Survival (OS)","type":"PRIMARY","unitOfMeasure":"months"}