{"analyses":[{"ciLowerLimit":"1.420","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"5.348","estimateComment":"Odds ratio was estimated using stratified Cochran-Mantel-Haenszel method.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"=0.0011","pValueComment":"1-sided p-value from stratified Cochran-Mantel-Haenszel (CMH) test.","paramType":"Odds Ratio (OR)","paramValue":"2.756","statisticalMethod":"Cochran-Mantel-Haenszel (CMH) test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"52.9","upperLimit":"74.4","value":"64.4"},{"groupId":"OG001","lowerLimit":"28.9","upperLimit":"50.6","value":"39.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"73"},{"groupId":"OG001","value":"74"}],"units":"Participants"}],"description":"ORR was defined as the percentage of participants who achieved BOR of confirmed CR or PR according to RECIST v 1.1 as assessed by BICR. CR: complete disappearance of all target lesions (with the exception of nodal disease) and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. PR: \\>=30% decrease under baseline of the sum of diameters of all target measurable lesions. PD: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, with minimum absolute increase of 5 mm for target disease or unequivocal progression of pre-existing lesions for non-target disease or any new lesion.","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 irinotecan 180 mg/m\\^2 as IV infusion for 90 minutes Q2W. Participants received treatment in 28-day cycles.","id":"OG000","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":"OG001","title":"Cohort 3: Arm E [FOLFIRI With or Without Bevacizumab]"}],"paramType":"NUMBER","populationDescription":"The FAS for Cohort 3 included all participants who were randomized in the Cohort 3 portion of the study.","reportingStatus":"POSTED","timeFrame":"From date of randomization until documented PD by BICR, or start of subsequent anticancer therapy or death, whichever occurred first (maximum up to 14.1 months)","title":"Cohort 3: ORR as Assessed by BICR for Arm D vs Arm E - FAS","type":"PRIMARY","unitOfMeasure":"Percentage of participants"}