{"analyses":[{"ciLowerLimit":"1.12","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.77","groupDescription":"The two-sided stratified Cochran-Mantel-Haenszel (CMH) test was employed at the 5% significance level, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and KPS:\\<80 vs. ≥80)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0038","paramType":"Odds Ratio (OR)","paramValue":"1.40","statisticalMethod":"Stratified cochran-mantel haenszel test","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"42.9","upperLimit":"51.0","value":"46.9"},{"groupId":"OG001","lowerLimit":"34.8","upperLimit":"42.8","value":"38.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"599"},{"groupId":"OG001","value":"599"}],"units":"Participants"}],"description":"The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).","dispersionType":"95% Confidence Interval","groups":[{"description":"Cetuximab intravenous infusion of 400mg/m\\^2 for the first infusion then weekly intravenous infusion of 250mg/m\\^2. Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops","id":"OG000","title":"Cetuximab Plus FOLFIRI"},{"description":"Bi-weekly Irinotecan infusion of 180mg/m\\^2, Folinic Acid infusion of 400mg/m\\^2 (racemic) or 200mg/m\\^2 (L-form), 5-Fluorouracil bolus of 400mg/m\\^2 followed by a 46-hour continuous infusion of 2400mg/m\\^2 Number of Cycles: until progression or unacceptable toxicity develops","id":"OG001","title":"FOLFIRI Alone"}],"paramType":"NUMBER","populationDescription":"ITT population (allocation to treatment groups as randomized and treated)","reportingStatus":"POSTED","timeFrame":"evaluations were performed every 6 weeks until progression reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006","title":"Best Overall Response Rate - Independent Review Committee (IRC) Assessments","type":"SECONDARY","unitOfMeasure":"percentage of participants"}