{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"7"}]}],"title":"Diastolic Blood Pressure - High"},{"categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"27"},{"groupId":"OG002","value":"5"}]}],"title":"Diastolic Blood Pressure - Low"},{"categories":[{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"20"}]}],"title":"Pulse Rate - High"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"3"}]}],"title":"Pulse Rate - Low"},{"categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"5"}]}],"title":"Systolic Blood Pressure - High"},{"categories":[{"measurements":[{"groupId":"OG000","value":"37"},{"groupId":"OG001","value":"28"},{"groupId":"OG002","value":"10"}]}],"title":"Systolic Blood Pressure - Low"},{"categories":[{"measurements":[{"groupId":"OG000","value":"33"},{"groupId":"OG001","value":"23"},{"groupId":"OG002","value":"25"}]}],"title":"Temperature - High"},{"categories":[{"measurements":[{"groupId":"OG000","value":"93"},{"groupId":"OG001","value":"84"},{"groupId":"OG002","value":"55"}]}],"title":"Temperature - Low"}],"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: low/high systolic blood pressure (SBP): \\<= 90 millimeters of mercury (mmHg) with decrease from baseline of \\>= 20mmHg or \\>= 160mmHg with increase from baseline of \\>= 20mmHg, low or high diastolic blood pressure (DBP): \\<= 50mmHg with decrease from baseline of \\>= 15mmHg or \\>= 100mmHg with increase from baseline of \\>= 15mmHg, low or high pulse: \\<= 50 beats/min with decrease from baseline of \\>= 15 beats/min or \\>= 120 beats/min with increase from baseline of \\>= 15 beats/min, low or high temperature: \\<= 36 degree Celsius (deg C) or \\>= 37.5 deg C.","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 Vital Sign Abnormalities","type":"SECONDARY","unitOfMeasure":"Participants"}