{"analyses":[{"ciLowerLimit":"-2.34","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"6.31","estimateComment":"Since stratified analyses could be based on collapsing strata with insufficient number of participants or events, strata were pooled in some cases based on clinical judgement and actual counts.","groupDescription":"Change from baseline to Week 18 in EORTC-QLQ-C30 GHS/QoL combined score was compared between all participants of the pembro combo arm and the SOC arm. Comparison based on cLDA model with GHS/QoL score as response variable and treatment by visit interaction and stratification factors (geographic region, disease status, and fluoropyrimidine treatment) as covariates.","groupIds":["OG001","OG002"],"nonInferiorityType":"OTHER","pValue":"0.368","pValueComment":"No formal hypothesis testing performed; nominal p-value provided for treatment comparison.","paramType":"Difference in LS Means","paramValue":"1.98","statisticalMethod":"cLDA"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"-3.36","upperLimit":"3.19","value":"-0.09"},{"groupId":"OG002","lowerLimit":"-5.43","upperLimit":"1.29","value":"-2.07"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"245"},{"groupId":"OG002","value":"243"}],"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 GHS question \"How would you rate your overall health during the past week?\" (Item 29) and the 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 compared between all participants of the pembro combo arm and the SOC arm as a pre-specified secondary analysis. As specified by the protocol, change from baseline to Week 18 in the GHS/QoL combined score was compared separately between all participants of the pembro mono arm and SOC arm and is presented earlier in the record.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 200 mg IV Q3W.","id":"OG000","title":"Pembrolizumab Monotherapy (Pembro Mono)"},{"description":"Participants received pembrolizumab 200 mg Q3W plus cisplatin 80 mg/m\\^2 Q3W plus 5-FU 800 mg/m\\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\\^2 twice a day (BID) on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.","id":"OG001","title":"Pembrolizumab + SOC Chemotherapy (Pembro Combo)"},{"description":"Participants received placebo IV Q3W plus cisplatin 80 mg/m\\^2 Q3W plus 5-FU 800 mg/m\\^2/day IV infusion on Days 1-5 Q3W. Capecitabine 1000 mg/m\\^2 BID on Days 1-14 Q3W could be substituted for 5-FU per local guidelines.","id":"OG002","title":"Placebo + SOC Chemotherapy (SOC)"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"Participants in the pembro combo arm and SOC arm who received ≥1 dose of study drug and who had EORTC-QLQ-C30 assessments available at baseline or post-baseline up to Week 18. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis.","reportingStatus":"POSTED","timeFrame":"Baseline, Week 18","title":"Pembro Combo vs SOC: Change From Baseline to Week 18 in the EORTC QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Combined Score","type":"SECONDARY","unitOfMeasure":"Score on a Scale"}