{"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"<0.0001","statisticalMethod":"Chi-squared"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"18.2","upperLimit":"35.3","value":"26.1"},{"groupId":"OG001","lowerLimit":"1.0","upperLimit":"9.3","value":"3.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"111"},{"groupId":"OG001","value":"107"}],"units":"Participants"}],"description":"ORR per RECIST, v1.1, was defined as the percentage of participants achieving an overall best response of CR or PR, where CR: disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (\\<10 mm short axis), and PR: at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits.","dispersionType":"95% Confidence Interval","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":"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":"OG001","title":"Phase 3:Control Arm"}],"paramType":"NUMBER","populationDescription":"The Phase 3 Response Efficacy Set consisted of the first 330 participants randomized into the Phase 3 portion of the study and any additional participants randomized on the same day as the 330th randomized participant. Here, \"Overall Number of Participants Analyzed\" signifies participants evaluable for this outcome measure.","reportingStatus":"POSTED","timeFrame":"Duration of Phase 3, approximately 6 months (up to 28 days per cycle)","title":"(Phase 3) Comparison of Objective Response Rate (ORR) in Triplet Arm vs Control Arm Per Investigator","type":"SECONDARY","unitOfMeasure":"Percentage of participants"}