{"analyses":[{"ciLowerLimit":"1.13","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"4.86","groupDescription":"Logistic regression was used to model the association of treatment arm (Arm 1 vs. 2 \\[reference level(RL)\\]), T stage (T3 vs.T1,T2 \\[RL\\]), Zubrod (1,2 vs. 0 \\[RL\\]), gender (male vs. female \\[RL\\]), presence of adenopathy (yes vs. no \\[RL\\]), and age (≥ 60 vs. \\<60 \\[RL\\]) with the occurrence of any cardiac AE, using backwards step-wise model selection requiring p≤0.05 for a covariate to remain in the model. Final model covariates are reported. Age is reported here. No other covariates reported.","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":"0.021","paramType":"Odds Ratio (OR)","paramValue":"2.35","statisticalMethod":"Regression, Logistic"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"30"},{"groupId":"OG001","value":"24"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"95"},{"groupId":"OG001","value":"96"}],"units":"Participants"}],"description":"Common Terminology Criteria for Adverse Events (version 4.0) grades adverse event (AE) severity from 1=mild to 5=death. Logistic regression was used to evaluate treatment arm, clinical tumor stage (T stage), Zubrod Performance Status, gender, presence of adenopathy, and age as possible predictors of cardiac adverse events. Results of the final model are reported in the statistical analysis section. Summary adverse event data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.","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":"COUNT_OF_PARTICIPANTS","populationDescription":"Eligible participants who started study treatment","reportingStatus":"POSTED","timeFrame":"From randomization to last follow-up. Maximum follow-up at time of analysis was 8 years.","title":"Number of Participants With Any Cardiac Adverse Events Regardless of Attribution","type":"SECONDARY","unitOfMeasure":"Participants"}