{"analyses":[{"ciLowerLimit":"-1.36","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.71","estimateComment":"Pembrolizumab minus placebo","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","otherAnalysisDescription":"Based on a cLDA model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratified by planned type of EBRT.","pValue":"0.5145","paramType":"Difference LS Means","paramValue":"0.68","statisticalMethod":"cLDA model"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.16","upperLimit":"4.33","value":"2.74"},{"groupId":"OG001","lowerLimit":"0.48","upperLimit":"3.65","value":"2.07"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"503"},{"groupId":"OG001","value":"506"}],"units":"Participants"}],"description":"The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=not at all to 4=very much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in physical function (EORTC QLQ-C30 Items 1-5) score will be presented.","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":"LEAST_SQUARES_MEAN","populationDescription":"Randomized participants who have at least 1 PRO assessment for QLQ-C30 available and have received at least 1 dose of study medication.","reportingStatus":"POSTED","timeFrame":"Baseline and week 36","title":"Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Function Score","type":"SECONDARY","unitOfMeasure":"Score on a scale"}