{"analyses":[{"ciLowerLimit":"3.9","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"12.7","estimateComment":"Estimate of (Nivolumab - Sorafenib) is based on CMH method of weighting, stratified by stratification factors","groupIds":["OG000","OG001"],"nonInferiorityComment":"no test was performed due to OS p-value result above the prior threshold","nonInferiorityType":"OTHER","paramType":"Difference of ORRs","paramValue":"8.3"},{"ciLowerLimit":"1.48","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.92","estimateComment":"Nivolumab over Sorafenib; Mantel-Haenszel estimator","groupIds":["OG000","OG001"],"nonInferiorityComment":"no test was performed due to OS p-value result above the prior threshold","nonInferiorityType":"OTHER","paramType":"Odds Ratio (OR)","paramValue":"2.41"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.8","upperLimit":"19.4","value":"15.4"},{"groupId":"OG001","lowerLimit":"4.6","upperLimit":"10.1","value":"7.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"371"},{"groupId":"OG001","value":"372"}],"units":"Participants"}],"description":"ORR is defined as the proportion of participants whose best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR is defined as the best response designation, as determined based on BICR-assessed tumor response according to RECIST 1.1, recorded between the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first. For participants without documented progression or subsequent anti-cancer therapy, all available response designations will contribute to the BOR determination. For a BOR of CR or PR, the initial response assessment must be confirmed by a consecutive assessment no less than 4 weeks (28 days) later.\n\nEstimate of (Nivolumab - Sorafenib) is based on CMH method of weighting, stratified by stratification factors","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":"NUMBER","populationDescription":"all randomized participants","reportingStatus":"POSTED","timeFrame":"the date of randomization and the date of first objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first, assessed up to May 2019 (approximately 40 months)","title":"Objective Response Rate (ORR) Per BICR RECIST 1.1","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}