{"analyses":[{"ciLowerLimit":"-29.6","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"-14.9","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":"ORR in CPS ≥1 participants of the pembro mono arm was compared to ORR in CPS ≥1 participants of the SOC arm based on Miettinen \\& Nurminen method stratified by geographic region, disease status, and Fluoropyrimidine treatment.","groupIds":["OG000","OG002"],"nonInferiorityType":"OTHER","pValue":">0.99999","pValueComment":"No formal hypothesis testing performed; nominal p-value provided for treatment comparison.","paramType":"Difference in ORR Percentage","paramValue":"-22.3","statisticalMethod":"Miettinen & Nurminen method"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"10.7","upperLimit":"19.8","value":"14.8"},{"groupId":"OG002","lowerLimit":"31.2","upperLimit":"43.5","value":"37.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"256"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"250"}],"units":"Participants"}],"description":"ORR was defined as the percentage of participants in the analysis population who have a CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. based upon BICR. Per protocol, ORR in the pembro mono arm was compared to the SOC arm as a pre-specified secondary analysis of the ITT population. The percentage of participants who experienced CR or PR is reported here as the ORR for all participants in the pembro mono arm and SOC arm who were PD-L1 CPS ≥1 (all participants). Per protocol, ORR was compared separately between CPS ≥1 participants of the pembro combo 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":"NUMBER","populationDescription":"All CPS ≥1 participants in the ITT population randomized to the pembro mono arm and SOC arm were analyzed. Per protocol, the pembro combo arm was compared to the SOC arm separately and not included in this analysis.","reportingStatus":"POSTED","timeFrame":"Up to approximately 42 months","title":"Pembro Mono vs SOC: ORR Per RECIST 1.1 by BICR in Participants With PD-L1 CPS ≥1 (All Participants)","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}