{"analyses":[{"ciLowerLimit":"0.33","ciNumSides":"TWO_SIDED","ciPctValue":"95.5","ciUpperLimit":"1.43","groupDescription":"Treatment A over Treatment B","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.2897","paramType":"Odds Ratio (OR)","paramValue":"0.68","statisticalMethod":"Mantel Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.4","upperLimit":"19.5","value":"13.2"},{"groupId":"OG001","lowerLimit":"10.6","upperLimit":"28.4","value":"18.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"159"},{"groupId":"OG001","value":"82"}],"units":"Participants"}],"description":"ORR is defined as best overall response (BOR) of a complete response (CR) or partial response (PR) divided by the number of randomized participants for each treatment group.\n\nComplete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to \\< 10 mm.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy.\n\nTreated with Nivolumab 3 mg/kg Q2W + Ipilimumab 1 mg/kg Q6W","id":"OG000","title":"Treatment A - Platinum Refractory Subgroup"},{"description":"Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) that has recurred during or less than 6 months after completion of previous platinum-based chemotherapy.\n\nTreated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W","id":"OG001","title":"Treatment B - Platinum Refractory Subgroup"}],"paramType":"NUMBER","populationDescription":"All Randomized Participants - Platinum Refractory Subgroup","reportingStatus":"POSTED","timeFrame":"Approximately up to 30 months (from FPFV to Data base lock)","title":"Objective Response Rate (ORR) as Determined by Blinded Independent Central Review (BIRC) - Platinum Refractory Subgroup","type":"PRIMARY","unitOfMeasure":"percentage of participants"}