{"analyses":[{"ciLowerLimit":"7.8","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"24.5","groupDescription":"Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.00013","paramType":"Percent difference","paramValue":"16.1","statisticalMethod":"Miettinen & Nurmimen"},{"ciLowerLimit":"9.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"25.6","groupDescription":"Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1)","groupIds":["OG000","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.00002","paramType":"Percent difference","paramValue":"17.2","statisticalMethod":"Miettinen & Nurmimen"},{"ciLowerLimit":"-10.6","ciPctValue":"95","ciUpperLimit":"8.6","groupDescription":"Statistical testing was stratified by line of therapy (1st vs. 2nd), PD-L1) status (positive vs. negative) and ECOG performance status (0 vs. 1)","groupIds":["OG001","OG002"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.82636","paramType":"Percent difference","paramValue":"-1.1","statisticalMethod":"Miettinen & Nurmimen"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.3","upperLimit":"16.3","value":"11.9"},{"groupId":"OG001","lowerLimit":"28.2","upperLimit":"39.6","value":"33.7"},{"groupId":"OG002","lowerLimit":"27.4","upperLimit":"38.7","value":"32.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"278"},{"groupId":"OG001","value":"279"},{"groupId":"OG002","value":"277"}],"units":"Participants"}],"description":"ORR was defined as the percentage of the participants with a best tumor response of complete response (CR: disappearance of all target lesions with any pathological lymph nodes having a reduction in short axis to \\<10 mm) or partial response (PR: ≥30% decrease in the sum of diameters of target lesions), based on IRO using RECIST 1.1. The primary analysis of ORR was performed at the time of the first protocol pre-specified statistical analysis, with data cut-off of 03-Sep-2014.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received ipilimumab, 3 mg/kg intravenously (IV), once every 3 weeks (Q3W) for a total of 4 doses (up to approximately 3 months).","id":"OG000","title":"Ipilimumab"},{"description":"Participants received pembrolizumab, 10 mg/kg IV, once every 2 weeks (Q2W) for up to approximately 24 months.","id":"OG001","title":"Pembrolizumab Q2W"},{"description":"Participants received pembrolizumab, 10 mg/kg IV, Q3W for up to approximately 24 months.","id":"OG002","title":"Pembrolizumab Q3W"}],"paramType":"NUMBER","populationDescription":"The ITT population, comprising all participants as randomized to a study arm.","reportingStatus":"POSTED","timeFrame":"Up to approximately 12 months (through first pre-specified statistical analysis cut-off date of 03-Sep-2014)","title":"Objective Response Rate (ORR) According to RECIST 1.1 as Assessed by IRO","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}