{"analyses":[{"ciLowerLimit":"6.0","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"27.0","groupDescription":"H0: difference in %=0 vs. H1: difference in % \\>0","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.0011","pValueComment":"One-sided p-value for testing","paramType":"Difference in percentages","paramValue":"16.6","statisticalComment":"Stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)","statisticalMethod":"Miettinen & Nurminem method"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"36.8","upperLimit":"53.0","value":"44.8"},{"groupId":"OG001","lowerLimit":"20.8","upperLimit":"35.7","value":"27.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"154"},{"groupId":"OG001","value":"151"}],"units":"Participants"}],"description":"ORR was defined as the percentage of participants in the analysis population who experienced a Complete Response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 based on BICR evaluation. ORR was assessed from enrollment/treatment initiation of a participant through data cutoff of 09-May-2016. The ORR is presented for each treatment group.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.","id":"OG000","title":"Pembrolizumab"},{"description":"Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m\\^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\\^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\\^2 and cisplatin 75 mg/m\\^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m\\^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m\\^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m\\^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).","id":"OG001","title":"SOC Chemotherapy"}],"paramType":"NUMBER","populationDescription":"The ITT population included all randomized participants. Participants were included in the treatment group to which they were randomized, regardless of whether or not they received study treatment.","reportingStatus":"POSTED","timeFrame":"Up to ~1.6 years","title":"Objective Response Rate (ORR)","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}