{"analyses":[{"ciLowerLimit":"-10.55","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-2.58","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-STO22 Pain symptom subscale 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":"0.001","pValueComment":"No formal hypothesis testing performed; nominal p-value provided for treatment comparison.","paramType":"Difference in LS Means","paramValue":"-6.56","statisticalMethod":"cLDA"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"-13.08","upperLimit":"-7.17","value":"-10.12"},{"groupId":"OG002","lowerLimit":"-6.61","upperLimit":"-0.51","value":"-3.56"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"245"},{"groupId":"OG002","value":"243"}],"units":"Participants"}],"description":"EORTC-QLQ-STO22 is a 22-item questionnaire developed to assess QoL of gastric cancer participants. It consists of 5 multi-item subscales that assess dysphagia (3 items), dietary restriction (4 items), pain (4 items), upper gastro-esophageal symptoms (3 items), and emotional problems (3 items), and questions on dry mouth, taste, body image, and hair loss. Participant responses to the Pain symptom subscale (Items 34-37) were scored on a 4-point scale (1=Not at all to 4=Very much). Raw scores were standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating more problems. Per protocol, change from baseline to Week 18 in the EORTC-QLQ-STO22 Pain score was compared between 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 EORTC-QLQ-STO22 Pain score was compared separately between 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-STO22 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 EORTC QLQ-STO22 Pain Symptom Subscale Score","type":"SECONDARY","unitOfMeasure":"Score on a Scale"}