{"analyses":[{"ciLowerLimit":"3.9","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"19.4","estimateComment":"Difference of disease control rates sorafenib minus placebo. Cochran-Mantel-Haenszel confidence interval stratified by age group and region","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0015","pValueComment":"stratified by age group and region","paramType":"Difference of response rates","paramValue":"11.7","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"80.6","upperLimit":"90.7","value":"86.2"},{"groupId":"OG001","lowerLimit":"68.0","upperLimit":"80.5","value":"74.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"196"},{"groupId":"OG001","value":"201"}],"units":"Participants"}],"description":"Disease control rate was defined as the proportion of subjects whose best response was complete response (CR), partial response (PR), or stable disease (SD). Per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, CR and PR were to be confirmed by another scan at least 4 weeks later; SD had to be documented at least 4 weeks after date of randomization. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum. SD = steady state of disease which is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle","id":"OG000","title":"Sorafenib (Nexavar, BAY43-9006)"},{"description":"Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle","id":"OG001","title":"Placebo"}],"paramType":"NUMBER","populationDescription":"Per protocol set (PPS). A participant was included in the PPS if he/she was randomized and was evaluable for tumor response based on imaging data, had exposure to study medication, and had no major protocol deviations.","reportingStatus":"POSTED","timeFrame":"From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years","title":"Disease Control Rate (DCR) Based on Central Assessment","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}