{"groups":[{"description":"Participants received 450 milligram (mg) of LGX818 orally once daily (QD) along with 45 mg of MEK162 twice daily (BID) for each 28 day treatment cycle until progressive disease (PD) as confirmed by Blinded Independent Review Committee (BIRC), withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.","id":"FG000","title":"Part 1: LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)"},{"description":"Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.","id":"FG001","title":"Part 1: LGX818 300 mg"},{"description":"Participants received 960 mg of Vemurafenib according to the locally approved prescribing information twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.","id":"FG002","title":"Part 1: Vemurafenib 960 mg BID"},{"description":"Participants received 300 mg of LGX818 orally once daily along with 45 mg of MEK162 twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.","id":"FG003","title":"Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)"},{"description":"Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.","id":"FG004","title":"Part 2: LGX818 300 mg"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"23"},{"groupId":"FG001","numSubjects":"24"},{"groupId":"FG002","numSubjects":"25"},{"groupId":"FG003","numSubjects":"25"},{"groupId":"FG004","numSubjects":"9"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"4"},{"groupId":"FG004","numSubjects":"1"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"11"},{"groupId":"FG003","numSubjects":"8"},{"groupId":"FG004","numSubjects":"2"}],"type":"New therapy for study indication"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"11"},{"groupId":"FG003","numSubjects":"10"},{"groupId":"FG004","numSubjects":"2"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"74"},{"groupId":"FG001","numSubjects":"81"},{"groupId":"FG002","numSubjects":"82"},{"groupId":"FG003","numSubjects":"93"},{"groupId":"FG004","numSubjects":"31"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"0"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"1"}],"type":"Study closure by Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"7"},{"groupId":"FG003","numSubjects":"15"},{"groupId":"FG004","numSubjects":"6"}],"type":"Subject/Guardian decision"},{"reasons":[{"groupId":"FG000","numSubjects":"36"},{"groupId":"FG001","numSubjects":"44"},{"groupId":"FG002","numSubjects":"42"},{"groupId":"FG003","numSubjects":"69"},{"groupId":"FG004","numSubjects":"32"}],"type":"Other"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"192"},{"groupId":"FG001","numSubjects":"194"},{"groupId":"FG002","numSubjects":"191"},{"groupId":"FG003","numSubjects":"258"},{"groupId":"FG004","numSubjects":"86"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"16"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"30"},{"groupId":"FG004","numSubjects":"2"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"170"},{"groupId":"FG001","numSubjects":"178"},{"groupId":"FG002","numSubjects":"185"},{"groupId":"FG003","numSubjects":"228"},{"groupId":"FG004","numSubjects":"84"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Study closure by sponsor was used for the end of study reason since the per-protocol final OS analysis was performed and the study ended by sponsor per the EOS.Participants remaining on treatment at that time were allowed to continue treatment and roll over into the FLOTILLA continuation study (C4221026/NCT05203172)or move to another treatment.","recruitmentDetails":"A total of 921 participants were enrolled in this study."}