{"analyses":[{"ciLowerLimit":"0.79","ciNumSides":"TWO_SIDED","ciPctValue":"90","ciUpperLimit":"1.18","estimateComment":"Reference level = Arm III","groupDescription":"316 deaths from step 2 randomized patients provides 80% power, with 0.05 1-sided alpha, to detect an OS increase (HR=0.76 in favor of arm IV), corresponding to increasing median OS from 17 to 22.5 months with the addition of RT. For analysis triggered by patients having 5 years potential follow-up from step 2 randomization, it is projected that at least 265 events will be observed, providing at least 72% power. The trigger used for the primary analysis was 5-years of follow-up (270 deaths).","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.38","pValueComment":"One-sided significance level = 0.05.","paramType":"Hazard Ratio (HR)","paramValue":"0.96","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"25.3","upperLimit":"37.6","value":"31.1"},{"groupId":"OG001","lowerLimit":"24.5","upperLimit":"31.7","value":"27.3"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"174"},{"groupId":"OG001","value":"180"}],"units":"Participants"}],"description":"Overall survival (OS) is estimated by the Kaplan-Meier method. Survival time is measured from step 2 randomization to date of death from any cause or last known follow-up (censored). Analysis was to occur at the earlier of 316 reported deaths or when all patients have five years potential follow-up from step 2 randomization.","dispersionType":"90% Confidence Interval","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 (RT) (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 the date of 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":"Overall Survival (Percentage of Participants Alive) [Phase III]","type":"PRIMARY","unitOfMeasure":"months"}