{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"910"},{"groupId":"OG001","value":"885"}]}],"title":"All adverse events"},{"categories":[{"measurements":[{"groupId":"OG000","value":"181"},{"groupId":"OG001","value":"182"}]}],"title":"Serious adverse events"}],"denoms":[{"counts":[{"groupId":"OG000","value":"995"},{"groupId":"OG001","value":"974"}],"units":"Participants"}],"description":"An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.","groups":[{"description":"Participants received capecitabine 1250 (mg/m \\^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).","id":"OG000","title":"Capecitabine"},{"description":"Participants received leucovorin 20 mg/m \\^ 2 followed by 5-fluorouracil at 425 mg/m \\^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).","id":"OG001","title":"5-Fluorouracil + Leucovorin"}],"paramType":"NUMBER","populationDescription":"The safety population comprises all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment","reportingStatus":"POSTED","timeFrame":"Up to Week 29","title":"Number of Participants With Any Adverse Events and Serious Adverse Events","type":"SECONDARY","unitOfMeasure":"Participants"}