{"analyses":[{"ciLowerLimit":"0.58","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.89","estimateComment":"Based on Cox regression model with Efron's method of tie handling","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0011","pValueComment":"One-sided p-value","paramType":"Hazard Ratio (HR)","paramValue":"0.72","statisticalComment":"Stratified by planned type of EBRT, stage at screening, and planned total radiotherapy dose.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"NA = Upper limit not reached at time of data cut-off due to insufficient number of participants with an event.","groupId":"OG000","lowerLimit":"48.9","upperLimit":"NA","value":"48.9"},{"comment":"NA = Median and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.","groupId":"OG001","lowerLimit":"46.8","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"529"},{"groupId":"OG001","value":"531"}],"units":"Participants"}],"description":"PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. The Kaplan-Meier nonparametric product limit method for censored data was used to estimate PFS.","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":"MEDIAN","populationDescription":"All randomized participants analyzed in the treatment group to which they were randomized.","reportingStatus":"POSTED","timeFrame":"Up to approximately 55 months","title":"PFS Per RECIST 1.1 as Assessed by Blinded Independent Central Review (BICR)","type":"SECONDARY","unitOfMeasure":"Months"}