{"analyses":[{"ciLowerLimit":"0.14","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.32","estimateComment":"From a Cox Model stratified by tumor sidedness (left vs. right) as entered into the IRT.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Arm B over Arm C","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"Boundary for statistical significance p-value \\< 0.0209.","paramType":"Hazard Ratio (HR)","paramValue":"0.21","statisticalComment":"Log-rank test stratified by the same factors as used in the Cox proportional hazard model.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"Insufficient number of participants with events based on Kaplan-Meier Estimates","groupId":"OG000","lowerLimit":"38.44","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"4.37","upperLimit":"7.79","value":"5.85"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"171"},{"groupId":"OG001","value":"84"}],"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 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":"OG000","title":"Arm B - Nivolumab + Ipilimumab"},{"description":"Participants received standard of care chemotherapy","id":"OG001","title":"Arm C - Investigator's Choice Chemotherapy"}],"paramType":"MEDIAN","populationDescription":"All randomized participants with centrally confirmed DNA mismatch repairdeficient/microsatellite instability-high metastatic colorectal cancer (dMMR/MSI-H mCRC) who have not received prior therapy for metastatic disease (1L) in Arm B and Arm C 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 32 months)","title":"Progression-free Survival (PFS) by Blinded Independent Review Center (BICR) - Arm B vs. Arm C 1L Participants Centrally Confirmed MSI-H/dMMR","type":"PRIMARY","unitOfMeasure":"Months"}