{"analyses":[{"ciLowerLimit":"0.67","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.91","estimateComment":"The hazard ratio was calculated as XELOX versus 5-FU/LV arms.","groupIds":["OG000","OG001"],"nonInferiorityComment":"Descriptive analysis only.","nonInferiorityType":"OTHER","pValue":"0.0015","paramType":"Hazard Ratio (HR)","paramValue":"0.78","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"comment":"The median time for RFS was not reached in this adjuvant trial; however, due to a late event in the XELOX arm and an artificial drop in the Kaplan-Meier estimate, an artificial median estimate for the XELOX groups appears.","groupId":"OG000","lowerLimit":"0","upperLimit":"95","value":"NA"},{"groupId":"OG001","lowerLimit":"0","upperLimit":"89","value":"88.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"942"},{"groupId":"OG001","value":"944"}],"units":"Participants"}],"description":"A relapse-free survival (RFS) event included recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants whose cause of death was unrelated to treatment or disease recurrence were censored at the time of the last tumor assessment. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.","dispersionType":"Full Range","groups":[{"description":"Given by one of two regimens. • Mayo Clinic regimen group: LV 20 mg/m\\^2 IV bolus injection + 5-FU 425 mg/m\\^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or • Roswell Park regimen group: LV 500 mg/m\\^2 by two-hour IV infusion + 5-FU 500 mg/m\\^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)","id":"OG000","title":"5-FU/LV"},{"description":"Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m\\^2 twice-daily (equivalent to a total daily dose of 2000 mg/m\\^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m\\^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)","id":"OG001","title":"XELOX"}],"paramType":"MEDIAN","populationDescription":"Intent-to-Treat (ITT) Population: all randomized participants who gave written informed consent. Participants in the ITT population were analyzed according to the treatment arm to which they were randomized.","reportingStatus":"POSTED","timeFrame":"Time from randomization date to date of first RFS event/date last known to be event-free. Median observation time for RFS was 74 months (range: 0-95 months).","title":"Relapse-Free Survival (RFS) [Time to Event]","type":"SECONDARY","unitOfMeasure":"months"}