{"analyses":[{"ciLowerLimit":"1.504","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"3.600","groupDescription":"A Cochran-Mantel-Haenszel (CMH) test was performed using the randomization strata previous CTX (no vs. yes) and KPS (\\<80 vs. ≥80). Treatment group comparisons were performed two-sided with α=5%.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0001","paramType":"Odds Ratio (OR)","paramValue":"2.326","statisticalMethod":"Cochran-Mantel-Haenszel","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"29.3","upperLimit":"42.3","value":"35.6"},{"groupId":"OG001","lowerLimit":"14.5","upperLimit":"25.4","value":"19.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"222"},{"groupId":"OG001","value":"220"}],"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 according to investigator (based on modified WHO criteria).","dispersionType":"95% Confidence Interval","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":"Analysis on ITT population (allocation to treatment groups as randomized). Analysis performed at clinical cut off date, determined by primary endpoint.","reportingStatus":"POSTED","timeFrame":"evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007","title":"Best Overall Response","type":"SECONDARY","unitOfMeasure":"percentage of participants"}