{"analyses":[{"ciLowerLimit":"0.774","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.995","groupDescription":"The two-sided stratified log-rank 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":"0.0419","paramType":"Hazard Ratio (HR)","paramValue":"0.878","statisticalComment":"Kaplan-Meier method was used to estimate median OS time. HR was calculated using Cox proportional hazards model stratified by randomization strata.","statisticalMethod":"Stratified log rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"18.5","upperLimit":"21.3","value":"19.9"},{"groupId":"OG001","lowerLimit":"16.7","upperLimit":"19.8","value":"18.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"599"},{"groupId":"OG001","value":"599"}],"units":"Participants"}],"description":"Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whichever is later.","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":"MEDIAN","populationDescription":"ITT population (allocation to treatment groups as randomized and treated)","reportingStatus":"POSTED","timeFrame":"Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 31 May 2009","title":"Overall Survival Time (OS)","type":"SECONDARY","unitOfMeasure":"months"}