{"groups":[{"description":"Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study intervention.","id":"FG000","title":"MEK162"},{"description":"Participants received chemotherapies as per treating physician's choice in accordance to the institutional standard of care. Participants received one of the three intravenous (IV) infusion therapies: Liposomal doxorubicin 40 milligram per meter square (mg/m\\^2) on Day 1 of each 28-day cycle or Paclitaxel 80 mg/m\\^2 on Days 1, 8, and 15 of each 28-day cycle or, Topotecan 1.25 mg/m\\^2 on Days 1 through 5 of each 21-day cycle. Participants were followed up to 30 days after last dose of study intervention.","id":"FG001","title":"Physician's Choice"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"89"},{"groupId":"FG001","numSubjects":"42"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"16"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"2"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"93"},{"groupId":"FG001","numSubjects":"48"}],"type":"Study Termination By Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"0"}],"type":"Completed as per protocol amendment 6"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"4"}],"type":"Other"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"228"},{"groupId":"FG001","numSubjects":"113"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"227"},{"groupId":"FG001","numSubjects":"106"}],"type":"Treated"},{"achievements":[{"comment":"The safety population number reported as \"At risk\" in AE section.","groupId":"FG000","numSubjects":"227"},{"comment":"The safety population number reported as \"At risk\" in AE section.","groupId":"FG001","numSubjects":"106"}],"comment":"Safety population consisted of all participants who received at any dose of study intervention (MEK162 or physician's choice chemotherapy).","type":"Safety Population"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"comment":"No data, safety or efficacy, were collected for crossover set, as the crossover period was stopped early.","groupId":"FG001","numSubjects":"18"}],"comment":"After failure of physician's choice chemotherapy in the randomized period, participants entered into the crossover period to receive MEK162 treatment 45 mg orally twice daily with water irrespective of food, continuously, starting on Day 1 of the crossover period. Crossover from physician's choice chemotherapy treatment to MEK162 treatment was no longer permitted after enrollment was early discontinued.","type":"Crossover Period"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"228"},{"groupId":"FG001","numSubjects":"113"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"As of the data cutoff date of 20 Jan 2016 for primary completion date (PCD), a total of 303 participants were enrolled, with 201 (200 treated) in MEK162 group and 102 (94 treated) in physician's choice group. After PCD, additional 27 participants were enrolled in MEK162 group and 11 in physician's choice group. Data reported was based on the last participant last visit date (23 Aug 2022). Note: one participant was enrolled before PCD and received the first dose after PCD."}