{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Baseline Grade 0 to Grade 2 post baseline"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}],"title":"Baseline Grade 0 to Grade 3 post baseline"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"205"},{"groupId":"OG002","value":"186"}]}],"title":"Baseline Grade 0 to missing grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"}]}],"title":"Baseline Grade 2 to missing grade"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Baseline missing grade to Grade 0 post baseline"}],"denoms":[{"counts":[{"groupId":"OG000","value":"222"},{"groupId":"OG001","value":"216"},{"groupId":"OG002","value":"193"}],"units":"Participants"}],"description":"Left ventricular ejection fraction (LVEF) abnormalities were defined according to CTCAE version 4.03 where Grade 0: Non-missing value below Grade 2, Grade 2: LVEF between 40% and 50% or absolute change from baseline between -10% and \\< -20%, Grade 3: LVEF between 20% and 39% or absolute change from baseline \\<= -20%, Grade 4: LVEF lower than 20%. Categories with at least 1 non-zero data values showing any shift in Grade from baseline to 1 day after dose 1 (post-baseline) were reported. Participants whose grade category was unchanged (e.g. Grade 0 to Grade 0) were not reported.","groups":[{"description":"Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.","id":"OG000","title":"Phase 3: Triplet Arm"},{"description":"Encorafenib + cetuximab. Encorafenib: Orally, once daily. Cetuximab: Standard of care.","id":"OG001","title":"Phase 3: Doublet Arm"},{"description":"Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab. Cetuximab: Standard of care. Irinotecan: Standard of care. Folinic Acid: Standard of care. 5-Fluorouracil: Standard of care. Following protocol amendment, eligible participants could crossover to receive either triplet or doublet regimen.","id":"OG002","title":"Phase 3: Control Arm"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-treatment assessment, which may have included death. Participants were analyzed according to treatment received.","reportingStatus":"POSTED","timeFrame":"From start of study treatment until 30 days post last dose of study treatment (for triplet arm: maximum treatment exposure of 277.4 weeks; for doublet arm: maximum treatment exposure of 268 weeks; for Control arm: maximum treatment exposure of 108 weeks)","title":"Phase 3: Number of Participants With Shifts in Left Ventricular Ejection Fraction (LVEF) From Baseline to Maximum Grade On-treatment","type":"SECONDARY","unitOfMeasure":"Participants"}