{"analyses":[{"ciLowerLimit":"1.0","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"22.6","estimateComment":"Based on Miettinen \\& Nurminen method.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.0159","pValueComment":"One-sided p-value based on Miettinen \\& Nurminen method.","paramType":"Difference in percentage","paramValue":"12.0","statisticalMethod":"Miettinen & Nurminen method"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"37.1","upperLimit":"53.3","value":"45.1"},{"groupId":"OG001","lowerLimit":"25.8","upperLimit":"41.1","value":"33.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"153"},{"groupId":"OG001","value":"154"}],"units":"Participants"}],"description":"ORR was defined as the percentage of the participants who experienced a Complete Response (CR; disappearance of all target lesions) or a Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions) and was assessed using RECIST 1.1 as assessed by the central imaging vendor. The percentage of participants who experienced a CR or PR was presented for the first course of study treatment per protocol.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle (Q3W) for up to 35 treatments (approximately 2 years). Eligible participants who stopped the initial course of pembrolizumab due to complete response (CR) or completed initial course of pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).","id":"OG000","title":"Pembrolizumab"},{"description":"Participants received 1 of 6 possible standard chemotherapy regimens: mFOLFOX6, or mFOLFOX6+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or mFOLFOX6+cetuximab 400 mg/m\\^2 IV over 2 hours then 250 mg/m\\^2 over 1 hour weekly in each 2-week cycle, or FOLFIRI, or FOLFIRI+bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle, or FOLFIRI+cetuximab 400 mg/m\\^2 IV over 2 hours then 250 mg/m\\^2 over 1 hour weekly in each 2-week cycle. Participants with documented disease progression following chemotherapy can crossover to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible cross over participants who stopped pembrolizumab who stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 year additional).","id":"OG001","title":"Standard of Care (SOC)"}],"paramType":"NUMBER","populationDescription":"All randomized participants","reportingStatus":"POSTED","timeFrame":"Up to approximately 59 months","title":"Overall Response Rate (ORR) Per RECIST1.1 as Assessed by Central Imaging Vendor","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}