{"analyses":[{"ciLowerLimit":"0.53","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.92","estimateComment":"Hazard ratio (HR) and the corresponding Confidence Interval (CI) were estimated in a stratified Cox proportional hazards model for distribution of OS in each randomized arm.","groupDescription":"Stratified Cox proportional hazard model. HR = Nivolumab over investigator's choice therapy (Cetuximab, Methotrexate, or Docetaxel)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0101","pValueComment":"Log-rank Test stratified by prior treatment with cetuximab (yes, no) as entered into the Interactive Voice Response System (IVRS). For OS the boundary for statistical significance requires the p-value to be less than 0.0227.","paramType":"Hazard Ratio (HR)","paramValue":"0.70","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"5.49","upperLimit":"9.10","value":"7.49"},{"groupId":"OG001","lowerLimit":"4.04","upperLimit":"6.05","value":"5.06"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"240"},{"groupId":"OG001","value":"121"}],"units":"Participants"}],"description":"OS was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Median OS time was calculated using Kaplan-Meier (KM) method.","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":"MEDIAN","populationDescription":"All randomized participants","reportingStatus":"POSTED","timeFrame":"From date of randomization to date of death (Up to approximately 18 months)","title":"Overall Survival (OS)","type":"PRIMARY","unitOfMeasure":"Months"}