{"analyses":[{"ciLowerLimit":"0.31","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.64","estimateComment":"Investigator-Assessed PFS. HR \\<1 indicates a lower risk with Trametinib compared with CT. HR from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"P-value from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.","paramType":"Hazard Ratio (HR)","paramValue":"0.44","statisticalMethod":"Log Rank"},{"ciLowerLimit":"0.29","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.60","estimateComment":"Independent Review PFS. HR \\<1 indicates a lower risk with Trametinib compared with CT. HR from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","pValueComment":"P-value from a stratified log-rank test was adjusted for prior chemotherapy for advanced or metastatic disease and Baseline lactate dehydrogenase.","paramType":"Hazard Ratio (HR)","paramValue":"0.41","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"3.5","upperLimit":"4.9","value":"4.8"},{"groupId":"OG001","lowerLimit":"1.4","upperLimit":"2.7","value":"1.4"}]}],"title":"Investigator-Assessed"},{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.5","upperLimit":"5.1","value":"4.9"},{"groupId":"OG001","lowerLimit":"1.4","upperLimit":"2.8","value":"1.6"}]}],"title":"Independent Review"}],"denoms":[{"counts":[{"groupId":"OG000","value":"178"},{"groupId":"OG001","value":"95"}],"units":"Participants"}],"description":"Progression-free survival (PFS) is defined as the time from randomization to the first documented occurrence of disease progression (PD) or death. PFS for investigator-assessed and blinded, independent, central review committee (BRIC)-assessed responses was summarized per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, which is a set of published rules defining when cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment. Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation. Primary Efficacy Population included all participants with BRAF V600E mutation-positive melanoma without a history of brain metastases.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signaling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 milligram (mg) tablet once daily until disease progression, death, or withdrawal.","id":"OG000","title":"Trametinib"},{"description":"Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.","id":"OG001","title":"Chemotherapy"}],"paramType":"MEDIAN","populationDescription":"Primary Efficacy Population","reportingStatus":"POSTED","timeFrame":"Day 1 until the earliest date of disease progression or death due to any cause (average of 20.3 months)","title":"Progression-free Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases as Assessed by the Investigator and Independent Review","type":"PRIMARY","unitOfMeasure":"Months"}