{"analyses":[{"ciLowerLimit":"0.70","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.02","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":"PFS in CPS ≥1 participants of the pembro combo arm was compared to PFS in CPS ≥1 participants of the SOC arm to address the first primary hypothesis (superiority to SOC). The comparison was based on a Cox regression model with Efron's method of tie handling with treatment as a covariate with stratification according to geographic region, disease status, and fluoropyrimidine treatment.","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY","pValue":"0.03918","pValueComment":"One-sided p-value based on log-rank test with stratification.","paramType":"Hazard Ratio (HR)","paramValue":"0.84","statisticalMethod":"Regression, Cox"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"5.7","upperLimit":"7.3","value":"6.9"},{"groupId":"OG002","lowerLimit":"5.7","upperLimit":"7.0","value":"6.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"257"},{"groupId":"OG002","value":"250"}],"units":"Participants"}],"description":"PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on BICR, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.\n\nPer protocol, PFS in the pembro combo arm was compared to the SOC arm as a pre-specified primary analysis of the Intent-To-Treat (ITT) population. PFS is reported here for all participants in the pembro combo arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, PFS was compared separately between CPS ≥1 participants of the pembro mono arm and SOC arm and is presented later 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":"MEDIAN","populationDescription":"All CPS ≥1 participants in the ITT population randomized to the pembro combo arm and SOC arm were analyzed. Per protocol, the pembro mono arm was compared to the SOC arm separately and not included in this analysis.","reportingStatus":"POSTED","timeFrame":"Up to approximately 36 months","title":"Pembro Combo vs SOC: Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1 (All Participants)","type":"PRIMARY","unitOfMeasure":"Months"}