{"analyses":[{"ciLowerLimit":"0.69","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"1.36","estimateComment":"Reference level = Chemoradiation arm","groupDescription":"Assuming a median DFS time of 15 months (Arm 2), hypothesized increase in DFS corresponding to median DFS time of 25 months (Arm 1). Assuming an exponential distribution and constant hazards, 183 HER2-positive participants accrued over 5 years and followed for 3 years would result in 162 disease-free survival events and provide 90% statistical power to detect this difference with a 2-sided α of 0.05 and 2 interim analyses. See Limitations and Caveats section.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.85","paramType":"Hazard Ratio (HR)","paramValue":"0.97","statisticalComment":"Two-sided significance level = 0.05","statisticalMethod":"Log Rank"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"13.5","upperLimit":"26.2","value":"19.6"},{"groupId":"OG001","lowerLimit":"10.5","upperLimit":"23.0","value":"14.2"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"98"},{"groupId":"OG001","value":"96"}],"units":"Participants"}],"description":"A disease event is defined as local/regional persistence or recurrence of the cancer under study, distant metastases, a new second primary cancer, or death due to any cause. Participants undergoing surgery who had an R2 resection and participants not undergoing surgery who had a positive endoscopic biopsy or no biopsy at all were considered to have local persistence of disease. Disease-free survival time is defined as time from randomization to the date of first disease event or last known follow-up (censored). Rates are estimated by the Kaplan-Meier method. Analysis was to occur after 162 events were reported.","dispersionType":"95% Confidence Interval","groups":[{"description":"Radiation therapy with concurrent trastuzumab, paclitaxel, and carboplatin followed by surgery followed by maintenance trastuzumab","id":"OG000","title":"Chemoradiation and Trastuzumab (Arm 1)"},{"description":"Radiation therapy with concurrent paclitaxel and carboplatin followed by surgery","id":"OG001","title":"Chemoradiation (Arm 2)"}],"paramType":"MEDIAN","populationDescription":"Eligible randomized participants","reportingStatus":"POSTED","timeFrame":"From randomization to last follow-up. Maximum follow-up at time of analysis was 8.0 years.","title":"Disease-free Survival (DFS)","type":"PRIMARY","unitOfMeasure":"months"}