{"analyses":[{"ciLowerLimit":"0.4484","ciPctValue":"95","ciUpperLimit":"0.7410","estimateComment":"This is the sorafenib to placebo hazard ratio.","groupDescription":"In the analysis of TTP, based on independent radiological review performed to review data up to 12 May 2006, the 2 treatment groups were compared using a 1-sided log rank test with an alpha of 0.025, stratified by region, ECOG PS, and \"tumor burden\".","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.000007","paramType":"Hazard Ratio (HR)","paramValue":"0.5764","statisticalMethod":"Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"126","upperLimit":"210","value":"168"},{"groupId":"OG001","lowerLimit":"82","upperLimit":"120","value":"86"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"299"},{"groupId":"OG001","value":"303"}],"units":"Participants"}],"description":"TTP was defined as the time from randomization to disease progression (radiological only). Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.","dispersionType":"95% Confidence Interval","groups":[{"description":"Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.","id":"OG000","title":"Sorafenib (Nexavar, BAY43-9006)"},{"description":"Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.","id":"OG001","title":"Placebo"}],"paramType":"MEDIAN","populationDescription":"The primary analysis of TTP for the ITT population was based on the independent radiological review for the interim analysis. The cut-off date chosen for the analysis of radiological progression events was 12 May 2006","reportingStatus":"POSTED","timeFrame":"from randomization to disease progression based on radiological assessment until an average 2.8 months later up to the data cut-off date approximately 19 months after start of enrollment","title":"Time to Progression (TTP)","type":"SECONDARY","unitOfMeasure":"days"}