{"analyses":[{"ciLowerLimit":"-1.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"5.9","estimateComment":"Pembrolizumab minus Placebo","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","otherAnalysisDescription":"Miettinen \\& Nurminen method stratified by planned type of EBRT, Stage at screening and planned total radiotherapy dose.","pValue":"0.1244","paramType":"Difference in Percentage","paramValue":"2.2","statisticalMethod":"One-sided p-value for testing."}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"87.7","upperLimit":"92.9","value":"90.5"},{"groupId":"OG001","lowerLimit":"85.3","upperLimit":"90.9","value":"88.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"527"},{"groupId":"OG001","value":"531"}],"units":"Participants"}],"description":"ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to \\<10mm) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions and includes no unequivocal progression in non-target lesions) per RECIST 1.1.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of pembrolizumab, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).","id":"OG000","title":"Chemoradiotherapy + Pembrolizumab"},{"description":"Participants received placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants received concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).","id":"OG001","title":"Chemoradiotherapy + Placebo for Pembrolizumab"}],"paramType":"NUMBER","populationDescription":"All randomized participants analyzed in the treatment group to which they were randomized. Participants with measurable disease at baseline. As the BICR and Investigator each measure and collect results differently, this can result in different numbers of participants with measurable disease at baseline, and hence different numbers analyzed.","reportingStatus":"POSTED","timeFrame":"Up to approximately 55 months","title":"ORR Per RECIST 1.1 as Assessed by BICR","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}