{"analyses":[{"ciLowerLimit":"0.26","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.55","estimateComment":"The hazard ratio for death for vemurafenib relative to dacarbazine and the associated 95% confidence interval were computed using an unstratified Cox regression model.","groupDescription":"The trial had a power of 80% to detect a hazard ratio of 0.65 for overall survival with an alpha level of 0.045 (an increase in median survival from 8 months for dacarbazine to 12.3 months for vemurafenib), one interim analysis for overall survival at 50% information.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.37","statisticalMethod":"Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"43"},{"groupId":"OG001","value":"75"}]}],"title":"Participants with events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"293"},{"groupId":"OG001","value":"261"}]}],"title":"Participants without events"}],"denoms":[{"counts":[{"groupId":"OG000","value":"336"},{"groupId":"OG001","value":"336"}],"units":"Participants"}],"description":"An Overall survival event was defined as death due to any cause. The number of participants with overall survival events is reported.","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 intent-to-treat (ITT) population was defined as all randomized participants, whether or not study treatment was received. The ITT population was analyzed according to the treatment assigned at randomization. Overall survival was assessed on participants randomized at least 15 days prior to the clinical cutoff date of December 30, 2010.","reportingStatus":"POSTED","timeFrame":"From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3).","title":"Overall Survival","type":"PRIMARY","unitOfMeasure":"participants"}