{"analyses":[{"ciLowerLimit":"0.728","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.000","groupDescription":"The study was planned with 633 progression events, in order to provide 80% power to test the null hypothesis of no difference in PFS time between treatment groups, assuming a hazard ratio (HR) of 0.8 of cetuximab + chemotherapy (CTX) over CTX alone. Significance level was fixed at 5%. The two-sided stratified log-rank test was employed, considering the randomization strata (region: Western Europe, Eastern Europe, outside Europe and Karnovsky Performance Scale (KPS):\\<80 vs. ≥80)","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0479","paramType":"Hazard Ratio (HR)","paramValue":"0.853","statisticalComment":"Kaplan-Meier method was used to estimate median PFS 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":"8.0","upperLimit":"9.4","value":"8.9"},{"groupId":"OG001","lowerLimit":"7.6","upperLimit":"9.0","value":"8.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"599"},{"groupId":"OG001","value":"599"}],"units":"Participants"}],"description":"Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause.\n\nOnly deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.","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":"Primary analysis on Intent to Treat (ITT) population i.e. all randomized subjects who have received at least one dose of randomized treatment (allocation to treatment groups as randomized).","reportingStatus":"POSTED","timeFrame":"Time from randomisation to disease progression, death or last tumour assessment, reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 27 July 2006","title":"Progression-free Survival (PFS) Time - Independent Review Committee (IRC) Assessments","type":"PRIMARY","unitOfMeasure":"months"}