{"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":"FG000","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":"FG001","title":"SLI: Cohort 2 [EC + mFOLFOX6]"},{"description":"Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.","id":"FG002","title":"Phase 3: Arm A [EC]"},{"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":"FG003","title":"Phase 3: Arm B [EC + mFOLFOX6]"},{"description":"Participants received standard of care (SOC) chemotherapy per Investigator's choice: mFOLFOX6 with or without bevacizumab or FOLFOXIRI with or without bevacizumab or CAPOX with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. mFOLFOX6 (28-day Cycle): 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; FOLFOXIRI (28-day Cycle): fluorouracil 2400 or 3200 mg/m\\^2 continuous IV infusion over 46-48 hours Q2W (per local standard of care); leucovorin 400 mg/m\\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\\^2 IV infusion for 120 minutes Q2W and irinotecan 165 mg/m\\^2 as IV infusion for 90 minutes Q2W; CAPOX (21-day Cycle): capecitabine 1000 mg/m\\^2 oral tablet twice daily on Days 1-14 and oxaliplatin 130 mg/m\\^2 IV infusion for 120 minutes Q3W.","id":"FG004","title":"Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]"},{"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 irinotecan 180 mg/m\\^2 as IV infusion for 90 minutes Q2W. Participants received treatment in 28-day cycles.","id":"FG005","title":"Cohort 3: Arm D [EC + FOLFIRI]"},{"description":"Participants received 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 with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. Participants received treatment in 28-day cycles.","id":"FG006","title":"Cohort 3: Arm E [FOLFIRI With or Without Bevacizumab]"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"18"},{"groupId":"FG001","numSubjects":"16"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"11"},{"groupId":"FG001","numSubjects":"9"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}],"type":"Ongoing"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"27"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"27"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Safety Lead-in"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"91"},{"groupId":"FG003","numSubjects":"94"},{"groupId":"FG004","numSubjects":"143"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"},{"groupId":"FG003","numSubjects":"2"},{"groupId":"FG004","numSubjects":"2"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"12"},{"groupId":"FG003","numSubjects":"8"},{"groupId":"FG004","numSubjects":"19"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"53"},{"groupId":"FG003","numSubjects":"132"},{"groupId":"FG004","numSubjects":"79"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}],"type":"Ongoing"}],"milestones":[{"achievements":[{"comment":"Period is for Phase 3 of the study.","groupId":"FG000","numSubjects":"0"},{"comment":"Period is for Phase 3 of the study.","groupId":"FG001","numSubjects":"0"},{"comment":"Period is for Phase 3 of the study.","groupId":"FG002","numSubjects":"158"},{"comment":"Period is for Phase 3 of the study.","groupId":"FG003","numSubjects":"236"},{"comment":"Period is for Phase 3 of the study.","groupId":"FG004","numSubjects":"243"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"158"},{"groupId":"FG003","numSubjects":"236"},{"groupId":"FG004","numSubjects":"243"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Phase 3"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"11"},{"groupId":"FG006","numSubjects":"20"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"2"},{"groupId":"FG006","numSubjects":"6"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"60"},{"groupId":"FG006","numSubjects":"47"}],"type":"Ongoing"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"comment":"Period is for Cohort 3 of the study.","groupId":"FG002","numSubjects":"0"},{"comment":"Period is for Cohort 3 of the study.","groupId":"FG003","numSubjects":"0"},{"comment":"Period is for Cohort 3 of the study.","groupId":"FG004","numSubjects":"0"},{"comment":"Period is for Cohort 3 of the study.","groupId":"FG005","numSubjects":"73"},{"comment":"Period is for Cohort 3 of the study.","groupId":"FG006","numSubjects":"74"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"0"},{"groupId":"FG006","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"0"},{"groupId":"FG004","numSubjects":"0"},{"groupId":"FG005","numSubjects":"73"},{"groupId":"FG006","numSubjects":"74"}],"type":"NOT COMPLETED"}],"title":"Cohort 3"}],"preAssignmentDetails":"Abbreviations used for treatments: encorafenib and cetuximab = EC; 5-fluorouracil/leucovorin (folinic acid)/irinotecan = FOLFIRI; modified 5-fluorouracil/leucovorin (folinic acid)/oxaliplatin = mFOLFOX6; 5-fluorouracil/leucovorin (folinic acid)/oxaliplatin/irinotecan = FOLFOXIRI; capecitabine/oxaliplatin = CAPOX.","recruitmentDetails":"Study had following parts: Safety lead-in (SLI), Phase 3 and Cohort 3. A total of 841 participants (57 participants in SLI, 637 participants in Phase 3 and 147 participants in Cohort 3) were enrolled in the study. Results are reported at Primary Completion Date, and data is disclosed for only those outcome measures whose analysis were final. Remaining outcome measures data would be reported upon their complete analyses at study completion date."}