{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"98.4"},{"groupId":"OG001","value":"97.6"},{"groupId":"OG002","value":"98.9"}]}],"title":"Participants with AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"38.1"},{"groupId":"OG001","value":"36.9"},{"groupId":"OG002","value":"37.0"}]}],"title":"Participants with SAEs"}],"denoms":[{"counts":[{"groupId":"OG000","value":"257"},{"groupId":"OG001","value":"84"},{"groupId":"OG002","value":"276"}],"units":"Participants"}],"description":"An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization/prolongation of existing hospitalization; resulted in persistent/significant disability/incapacity; results in congenital anomaly/birth defect or an important medical event. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms; Grade 2: moderate; Grade 3: severe/medically significant; Grade 4: life-threatening consequence; Grade 5: death. AEs and SAEs of all grades combined were reported.","groups":[{"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":"OG000","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":"OG001","title":"Part 2: LGX818 300 mg"},{"description":"Participants of Part 1 and 2 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, and study discontinuation, lost to follow-up or death.","id":"OG002","title":"Part 1 + Part 2: LGX818 300 mg"}],"paramType":"NUMBER","populationDescription":"Safety analysis set included all participants who received at least one dose of study medication and have at least one valid post-baseline safety evaluation.","reportingStatus":"POSTED","timeFrame":"Baseline up to 30 days after last dose of study drug (up to 106.3 M of treatment exposure for Part 2: LGX818+MEK162 45 mg; up to 98.4 M of treatment exposure for Part 2: LGX818 300 mg; up to 111.4 M of treatment exposure for Part 1+Part 2: LGX818 300 mg)","title":"Part 2: Percentage of Participants With AEs and SAEs as Graded by NCI-CTCAE, Version 4.03","type":"SECONDARY","unitOfMeasure":"Percentage of Participants"}