{"analyses":[{"ciLowerLimit":"0.497","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.168","groupDescription":"To test the equality of duration of response between treatment groups, the two-sided stratified log-rank test (α=5%) was used taking strata used for randomization into account (previous CTX \\[no vs. yes\\] and KPS \\[\\<80 vs. ≥80\\]).\n\nMedian duration of response was estimated using the Kaplan-Meier method. The 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":"0.21","paramType":"Hazard Ratio (HR)","paramValue":"0.762","statisticalMethod":"Stratified Log Rank","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"4.7","upperLimit":"6.0","value":"5.6"},{"groupId":"OG001","lowerLimit":"3.5","upperLimit":"5.9","value":"4.7"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"222"},{"groupId":"OG001","value":"220"}],"units":"Participants"}],"description":"Time from first assessment of Complete Response or Partial Response to disease progression or death (within 60 days of last tumor assessment).\n\nPatients without event are censored on the date of last tumor assessment. Tumor assessments 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":"MEDIAN","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":"time from first assessment of Complete Response or Partial Response to disease progression, death or last tumor assessment, reported between day of first patient randomised, 21 Dec 2004, until cut-off date 12 Mar 2007","title":"Duration of Response","type":"SECONDARY","unitOfMeasure":"months"}