{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"599"},{"groupId":"OG001","value":"597"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"600"},{"groupId":"OG001","value":"602"}],"units":"Participants"}],"description":"Please refer to Adverse Events section for further details","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":"Safety Population","reportingStatus":"POSTED","timeFrame":"time from first dose up to 30 days after last dose of study treatment reported between day of first patient randomised, 10 Aug 2004, until cut-off date, 30 Nov 2007","title":"Safety - Number of Patients Experiencing Any Adverse Event","type":"SECONDARY","unitOfMeasure":"participants"}