{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"218"},{"groupId":"OG001","value":"208"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"219"},{"groupId":"OG001","value":"215"}],"units":"Participants"}],"description":"Please refer to Adverse Events section for further details","groups":[{"description":"Subjects in will receive initial dose of 400 mg/m\\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\\^2 on day 1) + 5-FU (1000 mg/m\\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\\^2 continuous IV from day 1 to day 4) every 3 weeks.","id":"OG000","title":"Cetuximab Plus Chemotherapy"},{"description":"All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\\^2 on day 1) + 5-FU (1000 mg/m\\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\\^2 continuous IV from day 1 to day 4) every 3 weeks.","id":"OG001","title":"Chemotherapy Alone"}],"paramType":"NUMBER","populationDescription":"Safety population","reportingStatus":"POSTED","timeFrame":"time from first dose up to 30 after last dose of study treatment, reported between day of first dose of study treatment, 22 Dec 2004, until cut-off date 12 Mar 2007","title":"Safety - Number of Patients Experiencing Any Adverse Event","type":"SECONDARY","unitOfMeasure":"participants"}