{"analyses":[{"ciLowerLimit":"1.41","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"10.17","estimateComment":"Odds ratio (Nivolumab over Sorafenib) and associated unstratified 95% exact CI.","groupIds":["OG000","OG001"],"nonInferiorityComment":"PD-L1 \\>=1%, ORR; no test was performed","nonInferiorityType":"OTHER","paramType":"Odds Ratio (OR)","paramValue":"3.79"},{"ciLowerLimit":"1.10","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.45","estimateComment":"Odds ratio (Nivolumab over Sorafenib) and associated unstratified 95% exact CI","groupIds":["OG000","OG001"],"nonInferiorityComment":"PD-L1 \\<1%, ORR; no test was performed","nonInferiorityType":"OTHER","paramType":"Odds Ratio (OR)","paramValue":"1.95"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"18.1","upperLimit":"40.1","value":"28.2"},{"groupId":"OG001","lowerLimit":"3.5","upperLimit":"19.3","value":"9.4"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"64"}],"units":"Participants"}],"title":">=1%, ORR"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.7","upperLimit":"16.5","value":"12.2"},{"groupId":"OG001","lowerLimit":"4.1","upperLimit":"10.1","value":"6.7"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"295"},{"groupId":"OG001","value":"300"}],"units":"Participants"}],"title":"<1%, ORR"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"0.5","upperLimit":"71.6","value":"20.0"},{"groupId":"OG001","lowerLimit":"0.0","upperLimit":"36.9","value":"0.0"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"8"}],"units":"Participants"}],"title":"without PD-L1 quantifiable, ORR"}],"denoms":[{"counts":[{"groupId":"OG000","value":"371"},{"groupId":"OG001","value":"372"}],"units":"Participants"}],"description":"PD-L1 expression is defined as the percent of tumor cell membrane staining in a minimum of 100 evaluable tumor cells per Dako PD-L1 IHC assay unless otherwise specified. This is referred as quantifiable PD-L1 expression. If the PD-L1 staining could not be quantified, it is further classifies as:\n\nIndeterminate: Tumor cell membrane staining hampered for reasons attributed to the biology of the tumor biopsy specimen and not because of improper sample preparation or handling.\n\nNot evaluable: Tumor biopsy specimen was not optimally collected or prepared (e.g. PD-L1 expression is neither quantifiable nor indeterminate).\n\nPD-L1 status is a dichotomized variable using an X% cut-off for quantifiable PD-L1 expression:\n\n* PD-L1 \\> X %: ≥ X % PD-L1 expression\n* PD-L1 \\< X %: \\< X % PD-L1 expression where X% denotes the PD-L1 expression cut-off of 1%. Additional cut off values may also be explored.\n\nConfidence interval based on the Clopper and Pearson method.","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 with a \\>=1% PD-L1 expression all randomized participants with a \\<1% PD-L1 expression all randomized participants without PD-L1 quantifiable Note: odds ratio for participants without PD-L1 quantifiable cannot be estimated based on the data","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":"Efficacy Based on PD-L1 Expression - ORR","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}