{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"172"},{"groupId":"OG001","value":"70"},{"groupId":"OG002","value":"229"}]}],"title":"Grade 0"},{"categories":[{"measurements":[{"groupId":"OG000","value":"77"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"27"}]}],"title":"Grade 2"},{"categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"5"}]}],"title":"Grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Grade 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"15"}]}],"title":"Missing"}],"denoms":[{"counts":[{"groupId":"OG000","value":"257"},{"groupId":"OG001","value":"84"},{"groupId":"OG002","value":"276"}],"units":"Participants"}],"description":"LVEF values were graded as Grade 0: non missing value below Grade 2; Grade 2: LVEF between 40% and 50% or absolute reduction from baseline \\>=10% and \\< 20%; Grade 3: LVEF between 20% and 39% or absolute reduction from baseline \\>=20%; Grade 4: LVEF lower than 20%. Baseline was defined as the last non-missing value prior to the first dose of study treatment. Missing data were due to participants who died or withdrew consent prior to the first scheduled evaluation or missed evaluations as protocol deviations.","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":"COUNT_OF_PARTICIPANTS","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: Number of Participants With Worst Post-baseline LVEF Values by MUGA Scans or Transthoracic ECHO, by CTCAE Grade","type":"SECONDARY","unitOfMeasure":"Participants"}