{"analyses":[{"ciLowerLimit":"4.7","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"20.7","groupDescription":"ORR in ESCC participants of the pembrolizumab + SOC arm was compared to ORR in ESCC participants of the placebo + SOC arm based on the Miettinen \\& Nurminen method stratified by geographic region (Asia versus Rest of the World) and ECOG performance status (0 versus 1).","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.0009","paramType":"Difference in Percentage","paramValue":"12.8","statisticalMethod":"One-sided p-value"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"37.8","upperLimit":"49.9","value":"43.8"},{"groupId":"OG001","lowerLimit":"25.6","upperLimit":"36.9","value":"31.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"274"},{"groupId":"OG001","value":"274"}],"units":"Participants"}],"description":"ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. as assessed by the investigator. The sponsor allowed a maximum of 10 target lesions in total and 5 per organ on this study. Per protocol, the percentage of participants who experienced CR or PR is reported here as the ORR for all participants of the ITT population (all randomized) who had ESCC.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 200 mg IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\\^2 IV Q3W and 5-FU 800 mg/m\\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.","id":"OG000","title":"Pembrolizumab + SOC"},{"description":"Participants received placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\\^2 IV Q3W and 5-FU 800 mg/m\\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments were administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.","id":"OG001","title":"Placebo + SOC"}],"paramType":"NUMBER","populationDescription":"All randomized participants (ITT population) with ESCC were analyzed.","reportingStatus":"POSTED","timeFrame":"Up to approximately 34 months","title":"ORR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}