{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"27"}],"units":"Participants"}],"description":"DLT: Any AE/lab value during first 28 days (D) of treatment that met at least 1 criteria: AE/lab value unrelated to underlying disease,PD,intercurrent illness,concomitant medications resulting in inability to tolerate atleast 75% of planned dose intensity of study drug,fatigue grade (G)3\\>14 consecutive D, interstitial lung disease G\\>=2,rash,hand foot skin reaction G3\\>14 consecutive D or G4,diarrhea G3 \\>=48 hours or G4,nausea/vomiting G3\\>=48 hours or G4,mucositis G\\>=3,total bilirubin G\\>=3, aspartate aminotransferase/alanine aminotransferase G\\>=3 in conjunction with total bilirubin G\\>=2 or G3 \\>7 consecutive D or G4,Serum creatinine G\\>=3,absolute neutrophil count G4 \\>7 consecutive D, \\>=G3 febrile neutropenia,G3 platelet count decreased with signs of bleeding,platelet count G4,ECG QTcF prolonged \\>=G3,G\\>=3 uveitis \\>21 consecutive D,G4 confirmed by ophthalmic examination,paresthesia/dysesthesias G\\>=3,other G\\>=3 hematologic/nonhematologic toxicity except lymphocyte count decreased G\\>=3.","groups":[{"description":"Participants received encorafenib 300 milligrams (mg) once daily (QD) orally (received after Cycle 1 Day 3) and cetuximab 500 mg per square meters (mg/m\\^2) intravenous (IV) infusion for 120 minutes once every 2 weeks (Q2W) along with fluorouracil 400 mg/m\\^2 IV bolus then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\\^2 IV infusion for 120 minutes Q2W and irinotecan 180 mg/m\\^2 as IV infusion for 90 minutes Q2W. Participants received treatment in 28-day cycles.","id":"OG000","title":"SLI: Cohort 1 [EC + FOLFIRI]"},{"description":"Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\\^2 IV bolus then 2400 mg/m\\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.","id":"OG001","title":"SLI: Cohort 2 [EC + mFOLFOX6]"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"DLT evaluable analysis set included all participants who received at least 1 dose of study drug in the safety lead-in (SLI) and either experienced DLT during the DLT evaluation period or completed the DLT evaluation period without DLT.","reportingStatus":"POSTED","timeFrame":"Cycle 1 (28 days)","title":"SLI: Number of Participants With Dose Limiting Toxicity (DLTs)","type":"PRIMARY","unitOfMeasure":"Participants"}