{"analyses":[{"ciLowerLimit":"0.35","ciPctValue":"95","ciUpperLimit":"0.55","estimateComment":"Two treatment groups compared using log-rank test (Sorafenib over Placebo) stratified by country and Motzer category","groupDescription":"The planned final PFS analysis was to be performed when approximately 363 progressions or deaths (if death occurred before progression) were observed. The analysis had power of 90% to detect a 50% increase in PFS using a two-sided alpha of 0.01","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.000001","paramType":"Hazard Ratio (HR)","paramValue":"0.44","statisticalMethod":"Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"139","upperLimit":"174","value":"167"},{"groupId":"OG001","lowerLimit":"78","upperLimit":"91","value":"84"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"384"},{"groupId":"OG001","value":"385"}],"units":"Participants"}],"description":"PFS determined as the time (days) from the date of randomization at start of study to the actual date of disease progression (PD) (radiological or clinical) or death due to any cause, if death occurred before PD. Outcome measure was assessed approximately every 8 weeks using RECIST v1.0 criteria by independent radiologic review. Radiological PD defined as at least 20% increase in sum of longest diameter (LD) of measured lesions taking as reference smallest sum LD recorded since treatment started or appearance of new lesions.","dispersionType":"95% Confidence Interval","groups":[{"description":"Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.","id":"OG000","title":"Sorafenib (Nexavar, BAY43-9006)"},{"description":"Placebo tablets matching in appearance were to be orally administered twice a day.","id":"OG001","title":"Placebo"}],"paramType":"MEDIAN","populationDescription":"Evaluations based on ITT population as of 28Jan2005 data cut; 769 subjects randomized at that time. PFS determined as time from randomization to actual date of disease progression (PD) (radiological or clinical) or death, if death occurred before PD. Subjects without PD or death at time of analysis were censored at last date of tumor assessment.","reportingStatus":"POSTED","timeFrame":"From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.","title":"Final Progression-Free Survival (PFS) - Independent Radiological Review","type":"SECONDARY","unitOfMeasure":"days"}