{"analyses":[{"ciLowerLimit":"2.49","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"5.16","estimateComment":"Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab over Ipilimumab.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.0001","paramType":"Odds Ratio (OR)","paramValue":"3.59","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciLowerLimit":"4.38","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"9.22","estimateComment":"Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab + Ipilimumab over Ipilimumab.","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.0001","paramType":"Odds Ratio (OR)","paramValue":"6.35","statisticalMethod":"Cochran-Mantel-Haenszel"},{"ciLowerLimit":"19.1","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"32.8","estimateComment":"Difference in ORR and corresponding 95% CI is based on Cochran-Mantel-Haenszel (CMH) method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab - Ipilimumab.","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"Difference of Objective Response Rates","paramValue":"26.0"},{"ciLowerLimit":"32.2","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"45.9","estimateComment":"Difference in ORR and corresponding 95% CI is based on CMH method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab and Ipilimumab - Ipilimumab.","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"Difference of Objective Response Rates","paramValue":"39.0"},{"ciLowerLimit":"1.26","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"2.42","estimateComment":"Cochran-Mantel-Haenszel Test Stratified by PD-L1 Status, BRAF Status and M stage at screening as entered into the IVRS. Ratio of Nivolumab + Ipilimumab over Nivolumab","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"Odds Ratio (OR)","paramValue":"1.75"},{"ciLowerLimit":"5.7","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"20.7","estimateComment":"Difference in ORR and corresponding 95% CI is based on CMH method of weighting, adjusting for PD-L1 Status, BRAF Mutation Status and M-stage at screening as entered into the IVRS. Difference of Nivolumab and Ipilimumab - Nivolumab.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"Difference of Objective Response Rates","paramValue":"13.2"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"39.4","upperLimit":"50.6","value":"44.9"},{"groupId":"OG001","lowerLimit":"52.6","upperLimit":"63.8","value":"58.3"},{"groupId":"OG002","lowerLimit":"14.9","upperLimit":"23.8","value":"19.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"316"},{"groupId":"OG001","value":"314"},{"groupId":"OG002","value":"315"}],"units":"Participants"}],"description":"The ORR was defined as the percentage of participants with a best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each arm. The BOR was defined as the best response designation, as determined by the Investigator, recorded between the date of randomization and the date of progression, as assessed by the Investigator per RECIST 1.1 or the date of subsequent anticancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurred first. For participants without evidence of RECIST 1.1 progression or subsequent anticancer therapy, all available response designations contributed to the BOR assessment. CR= Disappearance of all evidence of disease, confirmed by PET scan; PR= Regression of measureable disease and no new sites; Stable Disease (SD)= Failure to attain CR/PR or PD; Progressive Disease (PD)= Any new lesion or increase by \\>=50% of previously involved sites from nadir.","dispersionType":"95% Confidence Interval","groups":[{"description":"Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity","id":"OG000","title":"Nivolumab"},{"description":"Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity","id":"OG001","title":"Nivolumab + Ipilimumab"},{"description":"Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses","id":"OG002","title":"Ipilimumab"}],"paramType":"NUMBER","populationDescription":"All randomized participants","reportingStatus":"POSTED","timeFrame":"From randomization until disease progression or death, whichever occurred first (assessed up to approximately 128 months)","title":"Objective Response Rate (ORR) Per Investigator Assessment","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}