{"analyses":[{"ciLowerLimit":"1.26","ciPctValue":"95","ciUpperLimit":"2.50","groupIds":["OG000","OG001"],"nonInferiorityComment":"Arm B over Arm A","nonInferiorityType":"SUPERIORITY","otherAnalysisDescription":"Stratified by tumor sidedness (left vs. right) and prior lines of therapy (0, 1, \\>= 2) as entered into the IRT","pValue":"0.0011","pValueComment":"Boundary for statistical significance p-value \\< 0.006","paramType":"Odds Ratio (OR)","paramValue":"1.77","statisticalComment":"Two-sided p-value from stratified CMH Test.","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"51.7","upperLimit":"63.5","value":"57.7"},{"groupId":"OG001","lowerLimit":"65.1","upperLimit":"75.7","value":"70.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"286"},{"groupId":"OG001","value":"296"}],"units":"Participants"}],"description":"Objective Response Rate (ORR) is defined as the percentage of all randomized participants whose best overall response is either confirmed complete response (CR) or confirmed partial response (PR).\n\nCR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.\n\nPR= At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.\n\nProgressive disease (PD)=At least a 20% increase in the sum of diameters of target lesions. the sum must also demonstrate an absolute increase of at least 5 mm.","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":"NUMBER","populationDescription":"All randomized participants with centrally confirmed DNA mismatch repairdeficient/microsatellite instability-high metastatic colorectal cancer (dMMR/MSI-H mCRC) in Arm A and Arm B only","reportingStatus":"POSTED","timeFrame":"From date of randomization to the date of the initial objectively documented tumor progression, or the date of initiation of subsequent therapy, whichever occurs first (Up to approximately 60 months)","title":"Objective Response Rate (ORR) by Blinded Independent Review Center (BICR) - Arm A and Arm B All Lines With dMMR/MSI-H mCRC","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}