{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"0"}]}],"title":"Heart Rate - Decrease from baseline > 25% and to a value < 50"},{"categories":[{"measurements":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"28"}]}],"title":"Heart Rate - Increase from baseline > 25% and to a value > 100"},{"categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"7"}]}],"title":"QT Interval - New > 450 millisecond (msec)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"2"}]}],"title":"QT Interval - New > 480 msec"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"0"}]}],"title":"QT Interval - New > 500 msec"},{"categories":[{"measurements":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"99"},{"groupId":"OG002","value":"32"}]}],"title":"QT Interval - increase from baseline > 30 msec"},{"categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"10"}]}],"title":"QT Interval - increase from baseline > 60 msec"},{"categories":[{"measurements":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"51"},{"groupId":"OG002","value":"23"}]}],"title":"QTcF - New > 450 msec"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"5"}]}],"title":"QTcF - New > 480 msec"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"2"}]}],"title":"QTcF - New > 500 msec"},{"categories":[{"measurements":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"75"},{"groupId":"OG002","value":"24"}]}],"title":"QTcF - increase from baseline > 30 msec"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"5"}]}],"title":"QTcF - increase from baseline > 60 msec"}],"denoms":[{"counts":[{"groupId":"OG000","value":"222"},{"groupId":"OG001","value":"216"},{"groupId":"OG002","value":"193"}],"units":"Participants"}],"description":"Newly occurring clinically notable changes was defined as participants not meeting the criterion at baseline and meeting criterion post-baseline. The criterion included: heart rate- decrease from baseline \\> 25% and to a value \\< 50 and increase from baseline \\> 25% and to a value \\> 100. QT interval- new \\> 450 (millisecond) msec, new \\> 480 msec, new \\> 500 msec, increase from baseline \\> 30 msec and increase from baseline \\> 60 msec. QTcF- new \\> 450 msec, new \\> 480 msec, new \\> 500 msec, increase from baseline \\> 30 msec and increase from baseline \\> 60 msec.","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 Newly Occurring Clinically Notable Electrocardiogram (ECG) Values","type":"SECONDARY","unitOfMeasure":"Participants"}