{"analyses":[{"ciLowerLimit":"0.39","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.57","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 (HR)","paramValue":"0.47","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":"44.5","upperLimit":"NA","value":"NA"},{"groupId":"OG001","lowerLimit":"12.7","upperLimit":"22.3","value":"16.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"438"},{"groupId":"OG001","value":"432"}],"units":"Participants"}],"description":"Freedom from relapse (FFR) was defined as the interval from randomization to local or distant recurrence with censoring of patients dying from causes other than melanoma or treatment -related toxicity at the date of death. The first appearance of local/distant metastasis or mortality due to disease recurrence or toxicity were used as events. Censoring was performed using the date of last assessment for those who were alive without local/distant metastasis or new primary melanoma at the time of analysis. FFR was censored if patients died from causes other than melanoma or treatment-related toxicity at the date of death.","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":"Freedom From Relapse (FFR)","type":"SECONDARY","unitOfMeasure":"Months"}