{"analyses":[{"ciLowerLimit":"0.644","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.986","groupDescription":"The primary analysis tested the equality of OS between treatment groups applying a 2-sided stratified log-rank test (α=5%), taking into account the strata used for randomization (previous chemotherapy (CTX) \\[no vs. yes\\] and Karnofsky Performance Status (KPS) \\[\\<80 vs. ≥80\\]).\n\nMedian overall survival was estimated using the Kaplan-Meier method. The Hazard Ratio (HR) of cetuximab + CTX over CTX alone was calculated using the Cox proportional hazards model stratified by randomization strata.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.036","paramType":"Hazard Ratio (HR)","paramValue":"0.797","statisticalMethod":"Stratified Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"8.6","upperLimit":"11.2","value":"10.1"},{"groupId":"OG001","lowerLimit":"6.4","upperLimit":"8.3","value":"7.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"222"},{"groupId":"OG001","value":"220"}],"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, whatever is earlier.","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":"MEDIAN","populationDescription":"Primary analysis on Intent to Treat (ITT) population (allocation to treatment groups as randomized).\n\nAnalysis performed after the required number of 340 deaths had been reported (expected effect: 36% increase in median survival time, power = 80%, alpha=5% (two-sided)). The Clinical cut-off date was 12 Mar 2007.","reportingStatus":"POSTED","timeFrame":"time from randomization to death or last day known to be alive, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007","title":"Overall Survival Time (OS)","type":"PRIMARY","unitOfMeasure":"months"}