{"analyses":[{"ciLowerLimit":"0.77","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.18","groupDescription":"The hazard ratio and CI were estimated from a stratified Cox proportional hazards model with the Breslow method to control for ties, the stratification factors age at randomization (\\<65 vs ≥65), sex (male vs female) and smoking history (smoker vs non-smoker) in the strata statement, and the CI calculated using a profile likelihood approach.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.664","pValueComment":"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.","paramType":"Hazard Ratio (HR)","paramValue":"0.95","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.5","upperLimit":"9.3","value":"7.4"},{"groupId":"OG001","lowerLimit":"4.2","upperLimit":"10.5","value":"5.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"476"},{"groupId":"OG001","value":"237"}],"units":"Participants"}],"description":"Global health status/HRQoL was assessed using the EORTC QLQ-C30 global QoL scale which includes 2 items from the QLQ-C30: \"How would you rate your overall health during the past week?\" (Item 29) and \"How would you rate your overall QoL during the past week?\" (Item 30). Scores from 0 to 100 were derived for each item with higher scores indicating a better health status. Time to deterioration for global health status/HRQoL was defined as time from randomization until the date of first clinically meaningful deterioration (a decrease in global health status/HRQoL from baseline of ≥10) or death (by any cause) in the absence of a clinically meaningful deterioration. Time to deterioration 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 ITT basis. Only patients with baseline scores ≥ 10 were included in the analysis.","reportingStatus":"POSTED","timeFrame":"At baseline, every 4 weeks for first 8 weeks, then every ~8 weeks until 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.","title":"Time to Deterioration of Global Health Status / Health-Related Quality of Life (HRQoL), Assessed Using European Organization for Research and Treatment of Cancer 30-Item Core Quality of Life Questionnaire (EORTC QLQ-C30)","type":"SECONDARY","unitOfMeasure":"Months"}