{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.1","upperLimit":"18.5","value":"7.7"},{"groupId":"OG001","lowerLimit":"11.9","upperLimit":"44.6","value":"25.8"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"52"},{"groupId":"OG001","value":"31"}],"units":"Participants"}],"title":"<1%"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"12.0","upperLimit":"29.1","value":"19.6"},{"groupId":"OG001","lowerLimit":"9.4","upperLimit":"33.9","value":"19.6"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"46"}],"units":"Participants"}],"title":"PD-L1: ≥ 1%"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.1","upperLimit":"18.3","value":"11.1"},{"groupId":"OG001","lowerLimit":"11.4","upperLimit":"33.9","value":"21.1"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"57"}],"units":"Participants"}],"title":"PD-L1: < 25%"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"16.5","upperLimit":"54.0","value":"33.3"},{"groupId":"OG001","lowerLimit":"8.7","upperLimit":"49.1","value":"25.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"20"}],"units":"Participants"}],"title":"PD-L1: ≥ 25%"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"7.9","upperLimit":"20.3","value":"13.2"},{"groupId":"OG001","lowerLimit":"13.3","upperLimit":"34.7","value":"22.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"129"},{"groupId":"OG001","value":"66"}],"units":"Participants"}],"title":"PD-L1: <50%"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.8","upperLimit":"61.6","value":"33.3"},{"groupId":"OG001","lowerLimit":"2.3","upperLimit":"51.8","value":"18.2"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"11"}],"units":"Participants"}],"title":"PD-L1: > 50%"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"6.5","upperLimit":"24.7","value":"13.8"},{"groupId":"OG001","lowerLimit":"4.4","upperLimit":"34.9","value":"15.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"26"}],"units":"Participants"}],"title":"PD-L1: 1 - < 25%"},{"categories":[{"measurements":[{"comment":"Not reported when sample size is less than 10 subjects for the subgroup category","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"Not reported when sample size is less than 10 subjects for the subgroup category","groupId":"OG001","lowerLimit":"NA","upperLimit":"NA","value":"NA"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"5"}],"units":"Participants"}],"title":"without quantifiable PD-L1 expression at baseline"}],"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 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\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":"Platinum Refractory subgroup","reportingStatus":"POSTED","timeFrame":"From randomization to end of study. Approximately 63 Months","title":"ORR - Platinum Refractory Subgroup Based on PD-L1 Expression","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}