{"analyses":[{"ciLowerLimit":"0.39","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.58","groupDescription":"The null hypothesis, H0: λ = 1 or reject it in favor of the alternative hypothesis, HA: λ ≠ 1, where λ is the hazard ratio (HR) of combination therapy relative to placebo.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Hazard ratio is obtained from the stratified Pike estimator. A hazard ratio \\<1 indicates a lower risk with Dabrafenib + Trametinib compared with Placebo.","nonInferiorityType":"SUPERIORITY","pValue":"< 0.0001","paramType":"Hazard Ratio, log","paramValue":"0.47","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":"22.1","value":"16.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"438"},{"groupId":"OG001","value":"432"}],"units":"Participants"}],"description":"Relapse-Free Survival (RFS) was defined as the time from randomization to disease recurrence or death from any cause. RFS events included loco-regional recurrence, distant metastases, new primary melanoma, and death without prior documented recurrence; such deaths were counted as events and not censored.\n\nPatients without an event at the analysis cut-off (30-Jun-2017) were censored at the date of the last radiological or non-radiological efficacy assessment. Patients lost to follow-up before recurrence or who initiated subsequent anti-cancer therapy prior to recurrence were censored at the last efficacy assessment before loss to follow-up or therapy initiation. Events after prolonged loss to follow-up were handled per the analysis plan.\n\nMalignancies other than new primary melanoma were not considered RFS events and, except for basal cell carcinoma, were reported as serious adverse events. Tumor tissue from any new primary cancer was collected for biomarker analyses.","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":"Relapse-free Survival (RFS)","type":"PRIMARY","unitOfMeasure":"Months"}