{"analyses":[{"ciLowerLimit":"0.830","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.169","estimateComment":"The HR and confidence interval (CI) were calculated using a stratified Cox proportional hazards model, adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status with ties handled by the Breslow approach.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.8637","pValueComment":"The 2-sided p-value was calculated using a stratified log-rank test adjusting for PD-L1 status, visceral metastases and cisplatin eligibility status.","paramType":"Hazard Ratio (HR)","paramValue":"0.99","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.3","upperLimit":"15","value":"13.2"},{"groupId":"OG001","lowerLimit":"10.9","upperLimit":"14","value":"12.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"346"},{"groupId":"OG001","value":"344"}],"units":"Participants"}],"description":"The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis were censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.","dispersionType":"95% Confidence Interval","groups":[{"description":"MEDI4736 (Durvalumab)","id":"OG000","title":"Monotherapy"},{"description":"Standard of Care Chemotherapy Treatment","id":"OG001","title":"Standard of Care"}],"paramType":"MEDIAN","populationDescription":"Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.","reportingStatus":"POSTED","timeFrame":"From randomization date until death due to any cause, assessed up to the data cut-off date (27JAN2020, a maximum of 5 years).","title":"OS, Full Analysis Set - Durvalumab Monotherapy vs SoC","type":"SECONDARY","unitOfMeasure":"Months"}