{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.4","upperLimit":"18.5","value":"9.0"},{"groupId":"OG001","lowerLimit":"9.3","upperLimit":"36.5","value":"20.5"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"39"}],"units":"Participants"}],"title":"TMB < 7"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.8","upperLimit":"38.6","value":"23.3"},{"groupId":"OG001","lowerLimit":"5.4","upperLimit":"41.9","value":"19.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"21"}],"units":"Participants"}],"title":"TMB ≥ 7"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.4","upperLimit":"19.3","value":"11.0"},{"groupId":"OG001","lowerLimit":"11.8","upperLimit":"36.6","value":"22.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"91"},{"groupId":"OG001","value":"49"}],"units":"Participants"}],"title":"TMB < 10"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"12.6","upperLimit":"56.6","value":"31.6"},{"groupId":"OG001","lowerLimit":"2.3","upperLimit":"51.8","value":"18.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"TMB ≥ 10"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.9","upperLimit":"27.2","value":"14.3"},{"groupId":"OG001","lowerLimit":"5.2","upperLimit":"40.3","value":"18.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"49"},{"groupId":"OG001","value":"22"}],"units":"Participants"}],"title":"TMB Not Reported"}],"denoms":[{"counts":[{"groupId":"OG000","value":"159"},{"groupId":"OG001","value":"82"}],"units":"Participants"}],"description":"ORR is defined as the 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\nTumor Mutational Burden (TMB) refers to the number of nonsynonymous somatic mutations that exist within a tumor's genome as measured by the Foundation One CDx panel at Foundation Medicine. The analysis was done on subjects with baseline tumor mutation burden by a cutoff of 7 mutations/megabase (mut/Mb) and 10 mut/Mb\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":"From randomization to end of study. Approximately 63 Months","title":"ORR - Platinum Refractory Subgroup Based on Tumor Mutation Burden (TMB) Biomarker","type":"SECONDARY","unitOfMeasure":"percentage of participants"}