{"analyses":[{"ciLowerLimit":"0.54","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.19","estimateComment":"Nivolumab over Sorafenib","groupIds":["OG000","OG001"],"nonInferiorityComment":"PD-L1 \\>= 1%, OS; no test was performed","nonInferiorityType":"OTHER","paramType":"Hazard Ratio (HR)","paramValue":"0.80"},{"ciLowerLimit":"0.48","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.03","estimateComment":"Nivolumab over Sorafenib","groupIds":["OG000","OG001"],"nonInferiorityComment":"PD-L1 \\>=1%, PFS; no test was performed","nonInferiorityType":"OTHER","paramType":"Hazard Ratio (HR)","paramValue":"0.71"},{"ciLowerLimit":"0.69","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.02","estimateComment":"Nivolumab over Sorafenib","groupIds":["OG000","OG001"],"nonInferiorityComment":"PD-L1 \\<1%, OS; no test was performed","nonInferiorityType":"OTHER","paramType":"Hazard Ratio (HR)","paramValue":"0.84"},{"ciLowerLimit":"0.81","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.17","estimateComment":"Nivolumab over Sorafenib","groupIds":["OG000","OG001"],"nonInferiorityComment":"PD-L1 \\<1%, PFS; no test was performed","nonInferiorityType":"OTHER","paramType":"Hazard Ratio (HR)","paramValue":"0.98"},{"ciLowerLimit":"0.34","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.74","estimateComment":"Nivolumab over Sorafenib","groupIds":["OG000","OG001"],"nonInferiorityComment":"without PD-L1 quantifiable, OS; no test was performed","nonInferiorityType":"OTHER","paramType":"Hazard Ratio (HR)","paramValue":"1.26"},{"ciLowerLimit":"0.27","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.52","estimateComment":"Nivolumab over Sorafenib","groupIds":["OG000","OG001"],"nonInferiorityComment":"without PD-L1 quantifiable, PFS; no test was performed","nonInferiorityType":"OTHER","paramType":"Hazard Ratio (HR)","paramValue":"0.98"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.41","upperLimit":"22.34","value":"16.07"},{"groupId":"OG001","lowerLimit":"5.72","upperLimit":"16.30","value":"8.62"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"64"}],"units":"Participants"}],"title":">=1%, OS"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.10","upperLimit":"7.62","value":"3.84"},{"groupId":"OG001","lowerLimit":"1.97","upperLimit":"5.36","value":"3.58"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"71"},{"groupId":"OG001","value":"64"}],"units":"Participants"}],"title":">=1%, PFS"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"13.93","upperLimit":"18.56","value":"16.72"},{"groupId":"OG001","lowerLimit":"12.58","upperLimit":"18.10","value":"15.24"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"295"},{"groupId":"OG001","value":"300"}],"units":"Participants"}],"title":"<1%, OS"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.43","upperLimit":"3.81","value":"3.61"},{"groupId":"OG001","lowerLimit":"3.71","upperLimit":"5.32","value":"3.75"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"295"},{"groupId":"OG001","value":"300"}],"units":"Participants"}],"title":"<1%, PFS"},{"categories":[{"measurements":[{"comment":"Upper limit cannot be estimated based on the data","groupId":"OG000","lowerLimit":"5.82","upperLimit":"NA","value":"16.23"},{"comment":"Upper limit cannot be estimated based on the data","groupId":"OG001","lowerLimit":"1.77","upperLimit":"NA","value":"22.05"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"8"}],"units":"Participants"}],"title":"without PD-L1 quantifiable, OS"},{"categories":[{"measurements":[{"comment":"Upper limit cannot be estimated based on the data","groupId":"OG000","lowerLimit":"1.87","upperLimit":"NA","value":"2.00"},{"groupId":"OG001","lowerLimit":"1.08","upperLimit":"11.17","value":"6.13"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"8"}],"units":"Participants"}],"title":"without PD-L1 quantifiable, PFS"}],"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":"MEDIAN","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","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 - OS and PFS","type":"SECONDARY","unitOfMeasure":"Months"}