{"analyses":[{"ciLowerLimit":"0.74","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.60","groupIds":["OG000","OG001"],"nonInferiorityComment":"ARFI was described using cumulative incidence curves. ARFI was compared between the two treatment arms using a Fine and Gray model.","nonInferiorityType":"SUPERIORITY","pValue":"0.658","pValueComment":"A 5% significance level was considered as a threshold for statistical significance.","paramType":"Hazard Ratio (HR)","paramValue":"1.09","statisticalMethod":"Fine and Gray model"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"61"},{"groupId":"OG001","value":"65"}],"title":"No event (censored)"},{"measurements":[{"groupId":"OG000","value":"46"},{"groupId":"OG001","value":"48"}],"title":"Abdominal recurrence"},{"measurements":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"20"}],"title":"Competing event (see outcome measure description)"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"133"},{"groupId":"OG001","value":"133"}],"units":"Participants"}],"description":"Abdominal recurrence was defined in the ARFS section. The following are considered competing events:\n\n* death in the absence of abdominal failure\n* distant metastases diagnosed before abdominal failure Patients without one of these events were censored at the date of last follow-up.","groups":[{"description":"En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated.\n\ntherapeutic conventional surgery","id":"OG000","title":"Surgery Alone"},{"description":"3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions\n\ntherapeutic conventional surgery\n\n3-dimensional conformal radiation therapy","id":"OG001","title":"Preoperative Radiotherapy Followed by En-bloc Surgery"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Note that distant metastasis before or in the absence of abdominal recurrence was counted as a competing risk for this endpoint - whereas distant metastasis in the absence of abdominal recurrence was considered a non-event for the primary endpoint (ARFS). This explains the difference in non-events between the survival and interval endpoint.","reportingStatus":"POSTED","timeFrame":"ARFI was measured from the date of randomization to the date of abdominal relapse, up to a maximum of 7 years","title":"Number of Patients With an Abdominal Recurrence","type":"SECONDARY","unitOfMeasure":"Participants"}