{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"557"},{"groupId":"OG001","value":"256"},{"groupId":"OG002","value":"855"}]}],"title":"Mild AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"493"},{"groupId":"OG001","value":"217"},{"groupId":"OG002","value":"792"}]}],"title":"Moderate AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"299"},{"groupId":"OG001","value":"146"},{"groupId":"OG002","value":"548"}]}],"title":"Severe AEs"},{"categories":[{"measurements":[{"groupId":"OG000","value":"83"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"63"}]}],"title":"Life-Threatening"}],"denoms":[{"counts":[{"groupId":"OG000","value":"657"},{"groupId":"OG001","value":"269"},{"groupId":"OG002","value":"938"}],"units":"Participants"}],"description":"The intensity of all adverse events (AEs) was categorized according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) (version 3.0) grading system. If an AE had occurred which was not contained in the NCI-CTC, a four-point scale (mild, moderate, severe, life-threatening) was used. The terms \"severe\" and \"serious\" are not synonymous and are independently assessed for each AE. Only the most severe intensity was counted for multiple occurrences of an AE in one individual. See the AEs results table for details.","groups":[{"description":"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)","id":"OG000","title":"5-FU/LV MAYO CLINIC"},{"description":"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":"OG001","title":"5-FU/LV ROSWELL PARK"},{"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":"OG002","title":"XELOX"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Safety Population: all participants who were randomized and did receive at least one dose of capecitabine, 5-FU, or oxaliplatin. Participants in the safety population were analyzed according to the study treatment they received.","reportingStatus":"POSTED","timeFrame":"From time of very first drug intake to 28 days after very last drug intake (median [full range] duration of study treatment per arm: 5-FU/LV MAYO CLINIC: 145 [4-208] days; 5-FU/LV ROSWELL PARK: 204 [1-239] days; XELOX: 163 [1-275] days).","title":"Number of Participants With at Least One Adverse Event by Most Severe Intensity","type":"SECONDARY","unitOfMeasure":"Participants"}