{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.0","upperLimit":"28.6","value":"15.7"},{"groupId":"OG001","lowerLimit":"7.5","upperLimit":"43.7","value":"21.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"51"},{"groupId":"OG001","value":"23"}],"units":"Participants"}],"title":"<1%"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"12.3","upperLimit":"33.5","value":"21.5"},{"groupId":"OG001","lowerLimit":"15.6","upperLimit":"48.7","value":"30.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"33"}],"units":"Participants"}],"title":"PD-L1: ≥ 1%"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.2","upperLimit":"24.2","value":"14.9"},{"groupId":"OG001","lowerLimit":"11.8","upperLimit":"41.2","value":"24.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"87"},{"groupId":"OG001","value":"37"}],"units":"Participants"}],"title":"PD-L1: < 25%"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"15.3","upperLimit":"50.8","value":"31.0"},{"groupId":"OG001","lowerLimit":"12.6","upperLimit":"56.6","value":"31.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"19"}],"units":"Participants"}],"title":"PD-L1: ≥ 25%"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.8","upperLimit":"25.6","value":"16.7"},{"groupId":"OG001","lowerLimit":"12.4","upperLimit":"40.3","value":"24.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"96"},{"groupId":"OG001","value":"41"}],"units":"Participants"}],"title":"PD-L1: <50%"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.9","upperLimit":"54.3","value":"30.0"},{"groupId":"OG001","lowerLimit":"11.8","upperLimit":"61.6","value":"33.3"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"15"}],"units":"Participants"}],"title":"PD-L1: > 50%"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.7","upperLimit":"29.5","value":"13.9"},{"groupId":"OG001","lowerLimit":"8.4","upperLimit":"58.1","value":"28.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"14"}],"units":"Participants"}],"title":"PD-L1: 1 - < 25%"},{"categories":[{"measurements":[{"comment":"Not reported when sample size is less than 10 subjects for the subgroup category,CI not calculable","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Not reported when sample size is less than 10 subjects for the subgroup category, CI not calculable","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"}],"units":"Participants"}],"title":"Without quantifiable PD-L1 expression at baseline"}],"denoms":[{"counts":[{"groupId":"OG000","value":"123"},{"groupId":"OG001","value":"61"}],"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 PD-L1 expression was defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per validated Dako PD-L1 IHC assay Complete 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) 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":"NUMBER","populationDescription":"Platinum Eligible Subgroup","reportingStatus":"POSTED","timeFrame":"From randomization to end of study. Approximately 63 Months","title":"ORR - Platinum Eligible Subgroup Based on PD-L1 Expression","type":"SECONDARY","unitOfMeasure":"percentage of participants"}