{"analyses":[{"ciLowerLimit":"-6.71","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.17","groupDescription":"Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between treatment arms based on a cLDA model with the EORTC-QLQ-C30 GHS/QoL scores as the response variable with covariates for treatment by study visit interaction, and stratification factors including geographic region (Asia versus Rest of the World) and tumor histology (Adenocarcinoma versus Squamous Cell Carcinoma).","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.4810","paramType":"Difference in LS Means","paramValue":"-1.77","statisticalMethod":"constrained Longitudinal Data Analysis"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-5.50","upperLimit":"2.04","value":"-1.73"},{"groupId":"OG001","lowerLimit":"-3.77","upperLimit":"3.85","value":"0.04"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"184"},{"groupId":"OG001","value":"191"}],"units":"Participants"}],"description":"The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question \"How would you rate your overall health during the past week?\" (Item 29) and the Quality of Life (QoL) question \"How would you rate your overall quality of life during the past week?\" (Item 30) were scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores were standardized so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome. Per protocol, change from baseline to Week 18 in the GHS/QoL combined score was reported by treatment arm as a pre-specified secondary analysis for all participants who were PD-L1 CPS ≥10.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\\^2 IV Q3W and 5-FU 800 mg/m\\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.","id":"OG000","title":"Pembrolizumab + SOC"},{"description":"Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\\^2 IV Q3W and 5-FU 800 mg/m\\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.","id":"OG001","title":"Placebo + SOC"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"All randomized participants who received at least one dose of study treatment, completed at least 1 EORTC-QLQ-C30 assessment, and who were PD-L1 CPS ≥10 were analyzed.","reportingStatus":"POSTED","timeFrame":"Baseline, Week 18","title":"Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)","type":"SECONDARY","unitOfMeasure":"Score on a Scale"}