{"analyses":[{"ciLowerLimit":"0.45","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.79","estimateComment":"Based on Cox regression model with Efron's method of tie handling with treatment as a covariate.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.59","statisticalComment":"One-sided p-value based on log rank test","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.4","upperLimit":"38.1","value":"16.5"},{"groupId":"OG001","lowerLimit":"6.1","upperLimit":"10.2","value":"8.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"153"},{"groupId":"OG001","value":"154"}],"units":"Participants"}],"description":"PFS was defined as the time from randomization to the first documented disease progression (PD) per RECIST 1.1 based on blinded central imaging vendor review or death due to any cause, whichever occurs 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. Hazards ratio (HR) and associated 95% confidence intervals (CIs) from a Cox proportional hazard model with Efron's method of tie handling and with a single treatment covariate was presented for the first course 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":"MEDIAN","populationDescription":"All randomized participants","reportingStatus":"POSTED","timeFrame":"Up to approximately 59 months","title":"Progression-Free Survival (PFS) Per RECIST1.1 As Assessed by Central Imaging Vendor","type":"PRIMARY","unitOfMeasure":"Months"}