{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"4"}]}],"title":"Activated Partial Thromboplastin Time - Hyper"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Hemoglobin - Hyper"},{"categories":[{"measurements":[{"groupId":"OG000","value":"97"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"17"}]}],"title":"Hemoglobin - Hypo"},{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}],"title":"Leukocytes - Hyper"},{"categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"51"}]}],"title":"Leukocytes - Hypo"},{"categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"4"}]}],"title":"Lymphocytes - Hyper"},{"categories":[{"measurements":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"47"},{"groupId":"OG002","value":"57"}]}],"title":"Lymphocytes - Hypo"},{"categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"65"}]}],"title":"Neutrophils - Hypo"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"4"}]}],"title":"Platelets - Hypo"},{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"2"}]}],"title":"Prothrombin Intl. Normalized Ratio - Hyper"}],"denoms":[{"counts":[{"groupId":"OG000","value":"222"},{"groupId":"OG001","value":"216"},{"groupId":"OG002","value":"193"}],"units":"Participants"}],"description":"Clinically notable shifts was defined as worsening by at least 2 grades or to more than or equal to (\\>=) Grade 3 based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 where Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life threatening and Grade 5: death.","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 Clinically Notable Shifts in Hematology and Coagulation Laboratory Parameters","type":"SECONDARY","unitOfMeasure":"Participants"}