{"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":"FG000","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":"FG001","title":"Chemotherapy"},{"description":"Participants randomized to chemotherapy and who did not receive subsequent anti-cancer therapy after discontinuing chemotherapy were allowed to cross-over to Trametinib and received 2 mg tablet once daily until disease progression, death or withdrawal.","id":"FG002","title":"Cross-over From Chemotherapy to Trametinib"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"0"}],"type":"Withdrew Consent"},{"reasons":[{"groupId":"FG000","numSubjects":"23"},{"groupId":"FG001","numSubjects":"14"},{"groupId":"FG002","numSubjects":"0"}],"type":"Study closed/ terminated"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"214"},{"groupId":"FG001","numSubjects":"108"},{"groupId":"FG002","numSubjects":"0"}],"comment":"Par. randomized onto study.","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"173"},{"groupId":"FG001","numSubjects":"77"},{"groupId":"FG002","numSubjects":"0"}],"comment":"Par. completed the study as they died during the conduct of the study.","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"41"},{"groupId":"FG001","numSubjects":"31"},{"groupId":"FG002","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Randomization and Crossover Phase"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"4"}],"type":"Withdrew Consent"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"11"}],"type":"Study closed/ terminated"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"comment":"As of the data cut on December 16, 2016, 70 of 108 participants crossed over from CT to trametinib.","groupId":"FG002","numSubjects":"70"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"53"}],"comment":"Par. completed the study as they died during the conduct of the study.","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"17"}],"type":"NOT COMPLETED"}],"title":"Cross-over Phase"}],"preAssignmentDetails":"Participants (par.) were stratified for lactate dehydrogenase and prior CT for advanced or metastatic disease. 1059 par. were screened and 322 were enrolled to receive trametinib (214 par.) or CT (108 par.) until disease progression, death, or withdrawal. Par. randomized to CT were allowed to cross-over to trametinib if disease progressed.","recruitmentDetails":"This was a randomized open-label, multi-center Phase III study to evaluate the efficacy and safety of single agent trametinib compared with chemotherapy (CT) (dacarbazine or paclitaxel). Participants (par.) were enrolled by 86 sites in 19 countries from December 2010 to July 2011. Results as of 16 December 2016 data-cut have been presented."}