{"analyses":[{"ciLowerLimit":"3.21","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"8.60","estimateComment":"The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFIRI alone arm.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"<0.0001","paramType":"Odds Ratio (OR)","paramValue":"5.33","statisticalComment":"Adjusted for ECOG score, prior bevacizumab exposure, prior oxaliplatin exposure.","statisticalMethod":"Stratified exact test"},{"ciLowerLimit":"0.56","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.76","estimateComment":"The odds ratio is defined as the odds of having an objective response in the panitumumab plus arm relative to the odds on the FOLFIRI alone arm.","groupIds":["OG002","OG003"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"1.0000","paramType":"Odds Ratio (OR)","paramValue":"1.00","statisticalComment":"Adjusted for ECOG score, prior bevacizumab exposure, prior oxaliplatin exposure.","statisticalMethod":"Stratified exact test"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"29.92","upperLimit":"41.08","value":"35.35"},{"groupId":"OG001","lowerLimit":"6.63","upperLimit":"13.89","value":"9.82"},{"groupId":"OG002","lowerLimit":"9.26","upperLimit":"18.43","value":"13.36"},{"groupId":"OG003","lowerLimit":"9.78","upperLimit":"19.00","value":"13.92"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"297"},{"groupId":"OG001","value":"285"},{"groupId":"OG002","value":"232"},{"groupId":"OG003","value":"237"}],"units":"Participants"}],"description":"Participants were evaluated for tumor response per the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria every 8 weeks until disease progression. Objective response was defined as the incidence of either a confirmed complete or partial response (CR or PR) while on study, as determined by blinded independent central review and confirmed no less than 4-weeks after the criteria for response are first met. CR: Disappearance of all target and non-target lesions and no new lesions. PR: At least a 30% decrease in the sum of the longest diameter of target lesions and no progression of non-target or no new lesions, or, disappearance of all target lesions and the persistence of ≥ 1 non-target lesion not qualifying for either CR or progressive disease. Participants without a post-baseline assessment were considered non-responders.","dispersionType":"95% Confidence Interval","groups":[{"description":"Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.","id":"OG000","title":"Wild-type KRAS - Panitumumab Plus FOLFIRI"},{"description":"Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.","id":"OG001","title":"Wild-type KRAS - FOLFIRI Alone"},{"description":"Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.","id":"OG002","title":"Mutant KRAS - Panitumumab Plus FOLFIRI"},{"description":"Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.","id":"OG003","title":"Mutant KRAS - FOLFIRI Alone"}],"paramType":"NUMBER","populationDescription":"KRAS Central Tumor Response Analysis Set: subset of participants with at least one uni-dimensionally measurable lesion per the modified RECIST criteria per blinded central radiology review for whom KRAS was assessed.","reportingStatus":"POSTED","timeFrame":"Every 8 weeks until disease progression up to the data cut-off date of 30 April 2009. Maximum time on follow-up was 33 months.","title":"Percentage of Participants With an Objective Response","type":"SECONDARY","unitOfMeasure":"percentage of participants"}