{"analyses":[{"ciLowerLimit":"0.62","ciPctValue":"95","ciUpperLimit":"0.97","estimateComment":"Two treatment groups compared using log-rank test (Sorafenib over Placebo) stratified by country and Motzer category","groupDescription":"Sample size based on primary efficacy endpoint of OS. Clinically meaningful improvement defined as 33.3% improvement in median OS (i.e. HR of 0.75, Sorafenib over Placebo). With overall two-sided alpha of 0.04, 90% power and randomization of 1:1, two formal interim analyses and one final analysis were planned using O'Brien-Fleming type error spending function, and a total of approximately 540 events (deaths) were required for the final analysis.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0287","pValueComment":"According to O'Brien-Fleming type alpha spending function and total actual deaths at final analysis, threshold for statistical significance was alpha=0.037 (two-sided).","paramType":"Hazard Ratio (HR)","paramValue":"0.78","statisticalMethod":"Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"500","upperLimit":"598","value":"542"},{"comment":"not estimable due to censored data.","groupId":"OG001","lowerLimit":"385","upperLimit":"NA","value":"436"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"451"},{"groupId":"OG001","value":"452"}],"units":"Participants"}],"description":"Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.","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":"Subjects received matching placebo tablets administered orally twice a day. \\[until \\~31 May 2005\\]","id":"OG001","title":"Placebo"}],"paramType":"MEDIAN","populationDescription":"Evaluations based on ITT population. Subjects alive at time of analysis were censored at last date of FU (last visit or contact or at data cut-off date). In case of incomplete date, missing day, day 15 was used. Placebo censored at 30June2005, approximate time of crossover of placebo subjects to sorafenib. NA - not estimable due to censored data.","reportingStatus":"POSTED","timeFrame":"From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later","title":"Final Overall Survival - Secondary Analysis (Placebo Data Censored at 30June2005) in the ITT Population","type":"PRIMARY","unitOfMeasure":"days"}