{"analyses":[{"ciLowerLimit":"-0.65","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.15","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":"0.2953","paramType":"Difference LS Means","paramValue":"0.75","statisticalMethod":"cLDA model"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-10.03","upperLimit":"-7.69","value":"-8.86"},{"groupId":"OG001","lowerLimit":"-10.78","upperLimit":"-8.43","value":"-9.60"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"503"},{"groupId":"OG001","value":"504"}],"units":"Participants"}],"description":"The EORTC QLQ-CX24 is a questionnaire that rates the symptoms common to women with cervical cancer and evaluates the impact of disease and/or treatments. The 24 items use a 4-point scale (1=not at all to 4=very much) and are classified into 3 multi-item scales, 11 items with symptom experience, 3 items with body image, and 4 items with sexual/ vaginal functioning. The other items of the questionnaire are lymphedema, peripheral neuropathy, menopausal symptom, sexual worry, sexual activity, and sexual enjoyment. Total scores are linearly transformed and range from 0 (no symptoms) to 100 (most severe symptoms). The change from baseline in EORTC QLQ-CX24 score is presented, with negative scores representing an improvement from baseline and vice versa.","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-CX24 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 Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score","type":"SECONDARY","unitOfMeasure":"Score on a scale"}