{"analyses":[{"ciLowerLimit":"0.79","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.10","estimateComment":"Nivolumab over Sorafenib; Stratified Cox proportional hazard model","groupIds":["OG000","OG001"],"nonInferiorityComment":"no test was performed due to OS p-value result above the prior threshold","nonInferiorityType":"OTHER","paramType":"Hazard Ratio (HR)","paramValue":"0.93"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.06","upperLimit":"3.88","value":"3.68"},{"groupId":"OG001","lowerLimit":"3.71","upperLimit":"4.47","value":"3.75"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"371"},{"groupId":"OG001","value":"372"}],"units":"Participants"}],"description":"PFS is defined as the time from the date of randomization to the date of the first objectively documented tumor progression as assessed by BICR according to RECIST 1.1 or death due to any cause in all randomized participants. Participants who die without a reported prior progression and without initiation of subsequent anti-cancer therapy will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last tumor assessment. Participants who did not have baseline tumor assessment will be censored on the date they were randomized. Participants who did not have any on study tumor assessments and did not die will be censored on the date they were randomized. Participants who started any subsequent anti-cancer therapy without a prior reported progression will be censored at the last tumor assessment prior to subsequent anti-cancer therapy.","dispersionType":"95% Confidence Interval","groups":[{"description":"Nivolumab 240 mg intravenously (IV) every 2 weeks until disease progression or unacceptable toxicity","id":"OG000","title":"Nivolumab 240 mg"},{"description":"Sorafenib 400 mg orally (PO) twice a day (BID) until disease progression or unacceptable toxicity","id":"OG001","title":"Sorafenib 400 mg"}],"paramType":"MEDIAN","populationDescription":"all randomized participants","reportingStatus":"POSTED","timeFrame":"time from the date of randomization to the date of the first objectively documented tumor progression or death, assessed up to May 2019 (approximately 40 months)","title":"Progression-Free Survival (PFS)","type":"SECONDARY","unitOfMeasure":"Months"}