{"analyses":[{"ciLowerLimit":"-19.56","ciPctValue":"95","ciUpperLimit":"-4.35","estimateComment":"Sorafenib minus placebo difference","groupDescription":"Disease control rates were compared between treatment groups using the Cochran Mantel Haenszel (CMH) test with a 1-sided alpha of 0.025, adjusting for region, ECOG PS, and \"tumor burden\".","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.001641","paramType":"Risk Difference (RD)","paramValue":"-11.95","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"130"},{"groupId":"OG001","value":"96"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"299"},{"groupId":"OG001","value":"303"}],"units":"Participants"}],"description":"The DC is defined as the number of subjects with a best response rating of complete response (CR), partial response (PR), or stable disease (SD) that is maintained at least 28 days from the first manifestation of that rating. Definitions: CR = disappearance of all clinical and radiological tumor lesions; PR = at least 30% decrease in sum of the longest diameters of tumor lesions; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease.","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":"NUMBER","populationDescription":"In this study, the DC for the ITT population was determined by independent radiological review and also by investigator assessment (both by using response evaluation criteria in solid tumors \\[RECIST\\])","reportingStatus":"POSTED","timeFrame":"time from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment","title":"Disease Control (DC)","type":"SECONDARY","unitOfMeasure":"Participants"}