{"analyses":[{"ciLowerLimit":"0.49","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.78","groupDescription":"OS in PD-L1 CPS ≥10 participants of the pembrolizumab + SOC arm was compared to OS in PD-L1 CPS ≥10 participants of the placebo + SOC arm based on a Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.62","statisticalMethod":"Stratified Log-Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.1","upperLimit":"15.6","value":"13.5"},{"groupId":"OG001","lowerLimit":"8.0","upperLimit":"10.7","value":"9.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"186"},{"groupId":"OG001","value":"197"}],"units":"Participants"}],"description":"Overall survival was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. Per protocol, OS is reported here for all participants of the ITT population (all randomized) who were PD-L1 CPS ≥10.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\\^2 IV Q3W and 5-FU 800 mg/m\\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.","id":"OG000","title":"Pembrolizumab + SOC"},{"description":"Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\\^2 IV Q3W and 5-FU 800 mg/m\\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.","id":"OG001","title":"Placebo + SOC"}],"paramType":"MEDIAN","populationDescription":"All randomized participants (ITT population) who were PD-L1 CPS ≥10 were analyzed.","reportingStatus":"POSTED","timeFrame":"Up to approximately 34 months","title":"OS in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)","type":"PRIMARY","unitOfMeasure":"Months"}