{"analyses":[{"ciLowerLimit":"0.407","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.677","estimateComment":"Hazard ratio was based on stratified Cox proportional hazards model.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","paramType":"Hazard Ratio (HR)","paramValue":"0.53","statisticalComment":"1-sided p-value from stratified log-rank test.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"11.2","upperLimit":"15.9","value":"12.8"},{"groupId":"OG001","lowerLimit":"6.8","upperLimit":"8.5","value":"7.1"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"236"},{"groupId":"OG001","value":"243"}],"units":"Participants"}],"description":"PFS was defined as the time from date of randomization to earliest documented disease progression (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or death due to any cause as assessed by BICR. PD: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, with minimum absolute increase of 5 millimeter (mm) for target disease or unequivocal progression of pre-existing lesions for non-target disease or any new lesion. Censoring details: no adequate baseline assessment, including no disease at baseline: participants were censored to randomization date; no PD, lost to follow-up, withdrawal of consent, PD or death \\>12 (or 16) weeks after the last adequate tumor assessment, and start of new anticancer treatment: participants were censored to last adequate tumor assessment documenting no PD prior to new anticancer therapy, or missed assessments. Analysis was performed using Kaplan Meier method.","dispersionType":"95% Confidence Interval","groups":[{"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":"OG000","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":"OG001","title":"Phase 3: Arm C [Standard of Care Chemotherapy, Control Arm]"}],"paramType":"MEDIAN","populationDescription":"The Full Analysis Set (FAS) for Phase 3 included all participants who were randomized in the Phase 3 portion of the study. As pre-specified in protocol of the study, this outcome measure was planned to compare PFS by BICR only between Arm B and Arm C of Phase 3. Hence, Arm A is not reported in this outcome measure.","reportingStatus":"POSTED","timeFrame":"From date of randomization to earliest documentation of PD by BICR or death or censoring date, whichever occurred first (maximum up to 37.25 months)","title":"Phase 3: Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) for Arm B vs Arm C - FAS","type":"PRIMARY","unitOfMeasure":"Months"}