{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.45","upperLimit":"3.06","value":"2.63"},{"groupId":"OG001","lowerLimit":"1.38","upperLimit":"9.59","value":"2.92"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"26"}],"units":"Participants"}],"title":"TMB: < 7"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.45","upperLimit":"12.42","value":"5.82"},{"groupId":"OG001","lowerLimit":"1.41","upperLimit":"13.01","value":"2.83"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"21"}],"units":"Participants"}],"title":"TMB: ≥ 7"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.45","upperLimit":"3.06","value":"2.63"},{"groupId":"OG001","lowerLimit":"1.41","upperLimit":"13.01","value":"2.99"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"81"},{"groupId":"OG001","value":"35"}],"units":"Participants"}],"title":"TMB: < 10"},{"categories":[{"measurements":[{"comment":"Insufficient number of events to calculate upper limit number.","groupId":"OG000","lowerLimit":"1.41","upperLimit":"NA","value":"6.97"},{"groupId":"OG001","lowerLimit":"0.72","upperLimit":"27.60","value":"2.76"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"12"}],"units":"Participants"}],"title":"TMB: ≥ 10"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"1.45","upperLimit":"8.48","value":"2.71"},{"groupId":"OG001","lowerLimit":"1.38","upperLimit":"9.82","value":"3.10"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"14"}],"units":"Participants"}],"title":"TMB: Not Reported"}],"denoms":[{"counts":[{"groupId":"OG000","value":"123"},{"groupId":"OG001","value":"61"}],"units":"Participants"}],"description":"the time from randomization to the date of first documented disease progression, or death due to any cause, whichever occurs first.\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\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more 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 Eligible Subgroup"},{"description":"Participants with histologically confirmed Squamous Cell Carcinoma of the Head and Neck (SCCHN) who are platinum naive or have recurred 6 months or more after completion of previous platinum-based chemotherapy.\n\nTreated with Nivolumab 3 mg/kg Q2W + Ipilimumab-Placebo Q6W","id":"OG001","title":"Treatment B - Platinum Eligible Subgroup"}],"paramType":"MEDIAN","populationDescription":"Platinum eligible subgroup all randomized","reportingStatus":"POSTED","timeFrame":"From randomization to disease progression or death. Approximately 63 Months","title":"Progression Free Survival (PFS) - Platinum Eligible Subgroup Based on Tumor Mutation Burden (TMB) Status","type":"SECONDARY","unitOfMeasure":"Months"}