{"analyses":[{"ciLowerLimit":"0.68","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"0.99","estimateComment":"Reference level = Arm III","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","paramType":"Hazard Ratio (HR)","paramValue":"0.82"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"9.6","upperLimit":"15.2","value":"12.4"},{"groupId":"OG001","lowerLimit":"13.2","upperLimit":"18.8","value":"15.6"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"174"},{"groupId":"OG001","value":"180"}],"units":"Participants"}],"description":"Disease-free survival is estimated by the Kaplan-Meier method. Disease-free survival time is measured from step 2 randomization to the first date of local or regional disease, distant metastases, second primary tumor, death due to any cause, or last known follow-up (censored). Analysis was to occur at the earlier of 316 reported deaths or when all participants have five years potential follow-up from second step randomization.","dispersionType":"90% Confidence Interval","groups":[{"description":"Patients receive the same treatment as in arm I for 1 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 for 1 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":"MEDIAN","populationDescription":"Participants randomized at step 2.","reportingStatus":"POSTED","timeFrame":"From step 2 randomization (chemotherapy vs. chemotherapy followed by chemoradiation) to disease event, 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":"Disease-free Survival (Percentage of Participants Alive Without Disease) [Phase III]","type":"SECONDARY","unitOfMeasure":"months"}