{"analyses":[{"ciLowerLimit":"21.1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"35.4","estimateComment":"Miettinen and Nurminen method with treatment as a covariate stratified by PD-L1 status (≥1% vs. \\<1%), platinum chemotherapy (cisplatin vs. carboplatin) \\& smoking status (never vs. former/current). Pembrolizumab=numerator; Control=denominator.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"H0:Difference in percentages=0 vs H1:Difference in percentages\\>0","paramType":"Difference in Percentage vs. Control","paramValue":"28.5","statisticalMethod":"Stratified Miettinen and Nurminen"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"42.6","upperLimit":"52.5","value":"47.6"},{"groupId":"OG001","lowerLimit":"13.8","upperLimit":"25.0","value":"18.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"410"},{"groupId":"OG001","value":"206"}],"units":"Participants"}],"description":"ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1. The percentage of participants who experienced a CR or PR is presented.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by pembrolizumab 200 mg IV PLUS pemetrexed 500 mg/m\\^2 IV Q3W until progression. (Participants who received pembrolizumab 200 mg IV Q3W for up to 2 years but experienced disease progression, were eligible to receive a second course of pembrolizumab monotherapy 200 mg IV Q3W, at the investigator's discretion, for up to 1 additional year.)","id":"OG000","title":"Pembrolizumab+Pemetrexed+Platinum Chemotherapy Followed by Pembrolizumab+Pemetrexed"},{"description":"Participants received saline placebo IV PLUS pemetrexed 500 mg/m\\^2 IV (with vitamin supplementation) PLUS cisplatin 75 mg/m\\^2 IV OR carboplatin AUC 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by saline placebo IV PLUS pemetrexed 500 mg/m\\^2 IV Q3W until progression. (Effective 23-Dec-2019, participants discontinued saline placebo. If documented disease progression had occurred, and participants receiving Control met certain criteria, they were eligible to switch over to receive pembrolizumab monotherapy Q3W for the remainder of the study.)","id":"OG001","title":"Control"}],"paramType":"NUMBER","populationDescription":"The analysis population consisted of all randomized participants.","reportingStatus":"POSTED","timeFrame":"Up to approximately 21 months","title":"Overall Response Rate (ORR) Per RECIST 1.1 as Assessed by Blinded Central Imaging","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}