{"analyses":[{"ciLowerLimit":"1.19","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.63","estimateComment":"All Randomized Participants","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Cox Proportional Hazard","paramValue":"1.40"},{"ciLowerLimit":"0.77","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.30","estimateComment":"All Randomized PD-L1 CPS \\>= 20 Participants","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Cox Proportional Hazard","paramValue":"1.00"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.83","upperLimit":"4.17","value":"3.29"},{"groupId":"OG001","lowerLimit":"5.78","upperLimit":"7.00","value":"6.77"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"472"},{"groupId":"OG001","value":"475"}],"units":"Participants"}],"title":"Randomized participants"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.09","upperLimit":"6.93","value":"5.39"},{"groupId":"OG001","lowerLimit":"5.78","upperLimit":"8.67","value":"6.97"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"185"},{"groupId":"OG001","value":"178"}],"units":"Participants"}],"title":"Randomized PD-L1 CPS >= 20 participants"}],"denoms":[{"counts":[{"groupId":"OG000","value":"472"},{"groupId":"OG001","value":"475"}],"units":"Participants"}],"description":"PFS is defined as the time between the date of randomization and the date of first documented tumor progression, based on Blinded Independent Central Review (BICR) assessments (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria), or death due to any cause, whichever occurs first. Participants who neither progress nor die will be censored on the date of their last tumor assessment. Participants who receive subsequent anti-cancer therapy prior to documented progression, will be censored on the date of their last tumor assessment prior to subsequent therapy. (Based on Kaplan-Meier Estimates)\n\nProgression is defined as at least a 20% increase in the sum of diameters of target lesions, in addition the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).","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 participants and randomized PD-L1 CPS \\>= 20 participants","reportingStatus":"POSTED","timeFrame":"From randomization to disease progression or death (Up to approximately 65 months)","title":"Progression Free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"Months"}