{"analyses":[{"ciLowerLimit":"0.42","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.65","groupDescription":"Analysis performed using a stratified log rank test adjusting for age at randomization (\\<65 vs ≥65), sex (male vs female), and smoking history (smoker vs non-smoker) with ties handled using the Breslow approach.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.52","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"13.0","upperLimit":"18.1","value":"16.8"},{"groupId":"OG001","lowerLimit":"4.6","upperLimit":"7.8","value":"5.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"476"},{"groupId":"OG001","value":"237"}],"units":"Participants"}],"description":"PFS was defined as the time from randomization until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression). Progression was defined using RECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. PFS was calculated using the Kaplan-Meier technique.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.","id":"OG000","title":"Durvalumab (MEDI4736)"},{"description":"Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.","id":"OG001","title":"Placebo"}],"paramType":"MEDIAN","populationDescription":"FAS included all randomized patients, analyzed on an intent-to-treat (ITT) basis.","reportingStatus":"POSTED","timeFrame":"Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 13 Feb 2017 DCO; up to a maximum of approximately 3 years.","title":"Progression Free Survival Based on Blinded Independent Central Review (BICR) According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)","type":"PRIMARY","unitOfMeasure":"Months"}