{"analyses":[{"ciLowerLimit":"-4.78","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.20","groupIds":["OG000","OG001"],"nonInferiorityComment":"Based on a constrained longitudinal data analysis (cLDA) model with the PRO scores as the response variable with covariates for treatment by study visit interaction, and stratification factors by primary tumor site, tumor stage, and PD-L1 status.","nonInferiorityType":"OTHER","pValue":"0.4671","pValueComment":"Two-sided p-value based on cLDA model.","paramType":"Difference in Least Square Means","paramValue":"-1.29","statisticalMethod":"cLDA model"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.03","upperLimit":"6.34","value":"3.69"},{"groupId":"OG001","lowerLimit":"2.26","upperLimit":"7.70","value":"4.98"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"356"},{"groupId":"OG001","value":"306"}],"units":"Participants"}],"description":"EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to questions regarding GHS (\"How would you rate your overall health during the past week?\") and QoL (\"How would you rate your overall quality of life during the past week?\") were scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) were computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores ranged from 0-100. A higher score indicated a better outcome. Per protocol, the change from baseline in GHS and QoL combined score for all randomized participants was presented.","dispersionType":"95% Confidence Interval","groups":[{"description":"Neoadjuvant treatment: Participants received 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of a 21-day cycle for 2 cycles (up to 6 weeks) prior to surgery.\n\nAdjuvant treatment: Following surgical resection, participants received 200 mg pembrolizumab, IV infusion, on Day 1 of a 21-day cycle for 15 cycles (up to 45 weeks) plus investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).","id":"OG000","title":"Pembrolizumab + Standard of Care (SOC)"},{"description":"Adjuvant treatment: Following surgical resection, participants received investigator's choice of SOC treatment regimen consisting of radiotherapy, with or without cisplatin 100 mg/m\\^2, IV infusion, on Day 1 of a 21-day cycle for 3 cycles (up to 9 weeks).","id":"OG001","title":"Standard of Care (SOC)"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"All randomized participants who received at least one dose of study treatment and had at least one EORTC QLQ-C30 assessment data available for this outcome measure at Baseline and at Week 25.","reportingStatus":"POSTED","timeFrame":"Baseline and Week 25","title":"Adjuvant Treatment: Change From Baseline in EORTC QLQ-C30 GHS/QoL (Items 29 and 30) Scale Combined Score at Week 25","type":"SECONDARY","unitOfMeasure":"Score on a scale"}