{"analyses":[{"ciLowerLimit":"7.0","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"16.5","estimateComment":"Difference of response rates sorafenib minus placebo. Cochran-Mantel-Haenszel confidence interval stratified by age group and region","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"stratified by age group and region","paramType":"Difference in response rate","paramValue":"11.8","statisticalMethod":"Cochran-Mantel-Haenszel"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.01","upperLimit":"17.67","value":"12.24"},{"groupId":"OG001","lowerLimit":"0.01","upperLimit":"2.74","value":"0.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"196"},{"groupId":"OG001","value":"201"}],"units":"Participants"}],"description":"Response rate was defined as the proportion of subjects whose best response was CR or PR. Per RECIST, CR and PR was to be confirmed by another scan at least 4 weeks later. 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.","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":"PPS","reportingStatus":"POSTED","timeFrame":"From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years","title":"Response Rate Based on Central Assessment","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}