{"analyses":[{"groupDescription":"The study hypothesis is that the addition of bevacizumab will improve the median survival by 35% from 8.5 months (based on E1395 and E5397) to 11.5 months.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.22","pValueComment":"The P value was based on stratified log rank test, stratified by choice of chemotherapy combination, performance status, weight loss in the last 6 months, and prior radiation of the head and neck.","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.5","upperLimit":"13.0","value":"11.0"},{"groupId":"OG001","lowerLimit":"10.3","upperLimit":"15.8","value":"12.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"200"},{"groupId":"OG001","value":"203"}],"units":"Participants"}],"description":"Overall survival (OS) was defined as time from randomization to death from any course. Patients who were alive were censored at the last contact date. Median OS was estimated using the Kaplan-Meier method.","dispersionType":"95% Confidence Interval","groups":[{"description":"ARM A: Patients receive one of the four chemotherapy regimens\n\nARM IA: Patients receive chemotherapy comprising docetaxel intravenously (IV) over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n\nARM IIA: Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n\nARM IIIA: Patients receive cisplatin IV over 1-2 hours on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.\n\nARM IVA: Patients receive carboplatin IV over 30 minutes on day 1 and fluorouracil IV continuously on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.","id":"OG000","title":"Chemotherapy Arm (Arm A)"},{"description":"ARM B: Patients receive bevacizumab in addition to the chemotherapy regimen as in arm A\n\nARM IB: Patients receive bevacizumab IV over 30-90 minutes on day 1 and docetaxel and cisplatin as in Arm IA.\n\nARM IIB: Patients receive bevacizumab as in arm IB and docetaxel and carboplatin as in Arm IIA.\n\nRegimen 2:\n\nARM IIIB: Patients receive bevacizumab as in Arm IB and cisplatin and fluorouracil as in Arm IIIA.\n\nRegimen 2 carbo:\n\nARM IVB: Patients receive bevacizumab as in Arm IB and carboplatin and fluorouracil as in Arm IVA.","id":"OG001","title":"Chemotherapy+Bevacizumab (Arm B)"}],"paramType":"MEDIAN","populationDescription":"All randomized patients","reportingStatus":"POSTED","timeFrame":"assessed every 3 months within 2 years from study entry, then every 6 months up to 5 years from study entry","title":"Overall Survival (OS)","type":"PRIMARY","unitOfMeasure":"months"}