{"analyses":[{"ciLowerLimit":"0.20","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.33","estimateComment":"Hazard ratios for treatment with vemurafenib, as compared with dacarbazine, were estimated with the use of unstratified Cox regression.","groupDescription":"The trial had a power of 90% to detect a hazard ratio of 0.55 for progression-free survival with an alpha level of 0.005 (an increase in median survival from 2.5 months for dacarbazine to 4.5 months for vemurafenib).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.26","statisticalMethod":"Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"104"},{"groupId":"OG001","value":"182"}]}],"title":"Participants with events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"171"},{"groupId":"OG001","value":"92"}]}],"title":"Participants without events"}],"denoms":[{"counts":[{"groupId":"OG000","value":"275"},{"groupId":"OG001","value":"274"}],"units":"Participants"}],"description":"A progression-free survival (PFS) event was defined as disease progression or death due to any cause. Tumor response (progression) was assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria using computed tomography (CT) scans or magnetic resonance imaging (MRI).","groups":[{"description":"Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).","id":"OG000","title":"Vemurafenib"},{"description":"Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).","id":"OG001","title":"Dacarbazine"}],"paramType":"NUMBER","populationDescription":"The analysis population for PFS consisted of all ITT participants randomized by October 27, 2010 (at least 9 weeks prior to the clinical cutoff date of December 30, 2010). The 9-week interval was chosen to allow time for participants to have had their first scheduled post baseline tumor assessment CT scan.","reportingStatus":"POSTED","timeFrame":"From randomization (initiated January 2010) to December 30 2010.","title":"Progression-free Survival","type":"PRIMARY","unitOfMeasure":"participants"}