{"analyses":[{"ciLowerLimit":"0.45","ciPctValue":"95","ciUpperLimit":"0.80","estimateComment":"from a Cox proportional hazard model stratified by tumor sidedness (left vs right) and prior lines of therapy (0, 1, ≥ 2) per IRT.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Arm B over Arm A","nonInferiorityType":"SUPERIORITY","paramType":"Hazard Ratio (HR)","paramValue":"0.60"}],"classes":[{"categories":[{"measurements":[{"comment":"Insufficient number of participants with events based on Kaplan-Meier Estimates","groupId":"OG000","lowerLimit":"24.80","upperLimit":"NA","value":"NA"},{"comment":"Insufficient number of participants with events based on Kaplan-Meier Estimates","groupId":"OG001","lowerLimit":"53.82","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"246"},{"groupId":"OG001","value":"257"}],"units":"Participants"}],"description":"BICR-assessed Progression-free survival (PFS) is defined as the time from the randomization date to the date of first objectively documented disease progression per RECIST 1.1 (i.e, radiologic) or death due to any cause, whichever occurs first.","dispersionType":"95% Confidence Interval","groups":[{"description":"Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.","id":"OG000","title":"Arm A - Nivolumab Monotherapy"},{"description":"Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.","id":"OG001","title":"Arm B - Nivolumab + Ipilimumab"}],"paramType":"MEDIAN","populationDescription":"All randomized participants with centrally confirmed microsatellite instability-high (MSI-H) in Arm A and Arm B only","reportingStatus":"POSTED","timeFrame":"From date of randomization to the date of first objectively documented disease progression or death due to any cause, whichever occurs first (Up to approximately 60 months)","title":"Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) by Polymerase Chain Reaction (PCR) - Arm B vs. Arm A","type":"SECONDARY","unitOfMeasure":"Months"}