{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"22"},{"groupId":"OG001","value":"16"}]}],"title":"Grade 1"},{"categories":[{"measurements":[{"groupId":"OG000","value":"50"},{"groupId":"OG001","value":"56"}]}],"title":"Grade 2"},{"categories":[{"measurements":[{"groupId":"OG000","value":"67"},{"groupId":"OG001","value":"79"}]}],"title":"Grade 3"},{"categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"23"}]}],"title":"Grade 4"},{"categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"}]}],"title":"Grade 5"}],"denoms":[{"counts":[{"groupId":"OG000","value":"174"},{"groupId":"OG001","value":"180"}],"units":"Participants"}],"description":"Assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 which grades adverse event severity from 1=mild to 5=death.","groups":[{"description":"Patients receive the same treatment as in arm I or arm II for one month. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.","id":"OG000","title":"Arm III (Chemotherapy)"},{"description":"Patients receive the same treatment as in arm I or arm II for one month. Beginning within 7-21 days after completion of chemotherapy, patients undergo radiotherapy (3-dimensional conformal radiotherapy or intensity modulated radiotherapy) 5 days per week for 5.5 weeks (28 fractions). During radiotherapy, patients receive either capecitabine PO BID 5 days per week or fluorouracil IV continuously for 5.5 weeks or until radiotherapy is completed. Patients undergo CT, MRI, and/or x-ray imaging throughout the trial. Patients also undergo blood sample collection during screening and follow-up and undergo tissue sample collection at baseline.","id":"OG001","title":"Arm IV (Chemotherapy, Chemoradiotherapy)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Participants randomized at step 2.","reportingStatus":"POSTED","timeFrame":"From step 2 randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to death or last follow-up. Maximum follow-up at time of the phase III analysis was 12.8 years, measured from step 2 randomization.","title":"Number of Participants by Highest Grade Adverse Event Reported (Phase III)","type":"SECONDARY","unitOfMeasure":"Participants"}