{"analyses":[{"ciLowerLimit":"0.40","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.65","groupDescription":"Hazard ratio is estimated using Pike estimator.","groupIds":["OG000","OG001"],"nonInferiorityComment":"A hazard ratio \\<1 indicates a lower risk with Dabrafenib + Trametinib compared with Placebo.","nonInferiorityType":"SUPERIORITY","pValue":"<.001","paramType":"Hazard Ratio, log","paramValue":"0.51","statisticalComment":"Hazard Ratio and p-value from stratified log-rank test are adjusted for randomized strata: Disease Stage and BRAF mutation status.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"N/A: Not Estimable due to number of events censored","groupId":"OG000","lowerLimit":"NA","upperLimit":"NA","value":"NA"},{"comment":"N/A: Not Estimable due to number of events censored","groupId":"OG001","lowerLimit":"41.2","upperLimit":"NA","value":"NA"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"438"},{"groupId":"OG001","value":"432"}],"units":"Participants"}],"description":"Distant metastasis-free survival (DMFS) was defined as the time from randomization to the first occurrence of distant metastasis or death, whichever occurred first, if death preceded documented recurrence. Patients who remained alive and free of distant metastasis were censored at the date of their last assessment.","dispersionType":"Full Range","groups":[{"description":"Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.","id":"OG000","title":"Dabrafenib and Trametinib Combination Therapy"},{"description":"Subjects received matching placebos orally for 12 months","id":"OG001","title":"Dabrafenib and Trametinib Placebos"}],"paramType":"MEDIAN","populationDescription":"Intent-to-Treat (ITT) Population","reportingStatus":"POSTED","timeFrame":"Approximately 4 years","title":"Distant Metastasis-free Survival (DMFS)","type":"SECONDARY","unitOfMeasure":"Months"}