{"analyses":[{"ciLowerLimit":"0.59","ciNumSides":"TWO_SIDED","ciPctValue":"97.51","ciUpperLimit":"1.03","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.0469","paramType":"Hazard Ratio (HR)","paramValue":"0.78","statisticalComment":"stratified regular log-rank test","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"13.77","upperLimit":"21.98","value":"17.58"},{"groupId":"OG001","lowerLimit":"12.32","upperLimit":"15.97","value":"14.59"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"185"},{"groupId":"OG001","value":"178"}],"units":"Participants"}],"description":"Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates)","dispersionType":"95% Confidence Interval","groups":[{"description":"Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.","id":"OG000","title":"Nivolumab + Ipilimumab"},{"description":"Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.","id":"OG001","title":"EXTREME Regimen"}],"paramType":"MEDIAN","populationDescription":"All randomized PD-L1 CPS \\>= 20 participants","reportingStatus":"POSTED","timeFrame":"From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months)","title":"Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20","type":"PRIMARY","unitOfMeasure":"Months"}