{"analyses":[{"ciLowerLimit":"1.5","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"13.6","estimateComment":"Stratum adjusted difference in response rates (Nivolumab - Investigators Choice) based on the Cochran-Mantel-Haenszel method of weighting.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Difference in ORR","paramValue":"7.6"},{"ciLowerLimit":"1.07","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"5.82","estimateComment":"Stratified by Prior Cetuximab (yes, no) as recorded in the IVRS. Stratum adjusted odds ratio (Nivolumab - Investigators Choice) using Mantel-Haenszel Method.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"CMH Estimate of Common Odds Ratio","paramValue":"2.49"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.3","upperLimit":"18.3","value":"13.3"},{"groupId":"OG001","lowerLimit":"2.4","upperLimit":"11.6","value":"5.8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"240"},{"groupId":"OG001","value":"121"}],"units":"Participants"}],"description":"ORR was defined as the percentage of randomized participants who achieved a best response of complete response (CR) or partial response (PR) using the RECIST1.1 criteria as per investigator assessment. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.","dispersionType":"95% Confidence Interval","groups":[{"description":"Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.","id":"OG000","title":"Nivolumab 3mg/kg"},{"description":"Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligrams per square meter (mg/m\\^2) for the first dose followed that a doses of 250 mg/m\\^2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m\\^2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m\\^2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice","id":"OG001","title":"Investigators Choice"}],"paramType":"NUMBER","populationDescription":"All randomized participants","reportingStatus":"POSTED","timeFrame":"From date of randomization to date of disease progression or study drug is discontinued, whichever occurs first (Up to approximately 87 months)","title":"Investigator-Assessed Objective Response Rate (ORR)","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}