{"analyses":[{"ciLowerLimit":"-3.7","ciPctValue":"95","ciUpperLimit":"-0.6","estimateComment":"difference in response rates (CR+PR) = Placebo - Sorafenib","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","paramType":"Difference in response rates (CR+PR)","paramValue":"-2.1","statisticalComment":"Adjustments for country and Motzer category","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.0"},{"groupId":"OG001","value":"0.0"}]}],"title":"Complete Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2.1"},{"groupId":"OG001","value":"0.0"}]}],"title":"Partial Response"},{"categories":[{"measurements":[{"groupId":"OG000","value":"77.9"},{"groupId":"OG001","value":"55.2"}]}],"title":"Stable Disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"8.7"},{"groupId":"OG001","value":"30.3"}]}],"title":"Progressive Disease"},{"categories":[{"measurements":[{"groupId":"OG000","value":"11.3"},{"groupId":"OG001","value":"14.5"}]}],"title":"Not Evaluated"}],"denoms":[{"counts":[{"groupId":"OG000","value":"335"},{"groupId":"OG001","value":"337"}],"units":"Participants"}],"description":"Best overall response was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 by independent radiologic review. Categories: complete response (CR, tumor disappears), partial response (PR, sum of lesion sizes decreased), stable disease (SD, steady state of disease), progressive disease (PD, sum of lesion sizes increased) and not evaluated.","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":"Placebo tablets matching in appearance were to be orally administered twice a day.","id":"OG001","title":"Placebo"}],"paramType":"NUMBER","populationDescription":"Evaluations of best overall response based on the valid for response population, where as per protocol, subjects were to have first post-baseline tumor evaluation performed at the end of Cycle 1 (6 weeks post-randomization). Of the ITT population that met this criteria as of the 28Jan2005 data cut, 672 subjects were valid for response.","reportingStatus":"POSTED","timeFrame":"From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.","title":"Best Overall Response - Independent Radiological Review","type":"SECONDARY","unitOfMeasure":"percentage of participants"}