{"analyses":[{"ciLowerLimit":"0.79","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.24","estimateComment":"Adjusted Hazard Ratio, ECF vs 5-FU/LV","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","paramType":"Cox Proportional Hazard","paramValue":"0.99"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"2.8","upperLimit":"4.9","value":"3.6"},{"groupId":"OG001","lowerLimit":"2.5","upperLimit":"5.0","value":"3.5"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"280"},{"groupId":"OG001","value":"266"}],"units":"Participants"}],"description":"Overall survival is defined as the time from study enrollment to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.","dispersionType":"95% Confidence Interval","groups":[{"description":"Patients receive leucovorin calcium (LV) IV (20 mg/m\\^2 per day) and fluorouracil (5-FU) IV (425 mg/m\\^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.","id":"OG000","title":"Arm I (5-FU/LV)"},{"description":"Patients receive epirubicin IV (50 mg/m\\^2) over 3-15 minutes and cisplatin IV (60 mg/m\\^2) over 1 hour on day 1 and 5-FU IV (200 mg/m\\^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.","id":"OG001","title":"Arm II (ECF)"}],"paramType":"MEDIAN","reportingStatus":"POSTED","timeFrame":"From study enrollment until death from any cause; up to 3 years","title":"Overall Survival","type":"PRIMARY","unitOfMeasure":"years"}