{"eventGroups":[{"description":"radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.\n\nAnalysis of adverse events were based on the 927 patients who actually received Standard Breast Irradiation treatment. A total of 908 patients who were randomized to Standard Breast Irradiation and 19 patients who were randomized to Breast Radiation plus regional radiation actually received the Standard Breast Irradiation treatment.","id":"EG000","otherNumAffected":745,"otherNumAtRisk":927,"seriousNumAffected":1,"seriousNumAtRisk":927,"title":"Standard Breast Irradiation"},{"description":"regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)\n\nBreast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.\n\nAnalysis of adverse events were based on the 893 patients who actually received Breast Radiation plus regional radiation treatment. A total of 5 patients who were randomized to Standard Breast Irradiation and 888 patients who were randomized to Breast Radiation plus regional radiation actually received the Breast Radiation plus regional radiation treatment.","id":"EG001","otherNumAffected":752,"otherNumAtRisk":893,"seriousNumAffected":3,"seriousNumAtRisk":893,"title":"Breast Radiation Plus Regional Radiation"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":180,"numAtRisk":927},{"groupId":"EG001","numAffected":226,"numAtRisk":893}],"term":"Lymphedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":353,"numAtRisk":927},{"groupId":"EG001","numAffected":343,"numAtRisk":893}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":252,"numAtRisk":927},{"groupId":"EG001","numAffected":233,"numAtRisk":893}],"term":"Pain due to radiation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":69,"numAtRisk":927},{"groupId":"EG001","numAffected":89,"numAtRisk":893}],"term":"Joint"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":313,"numAtRisk":927},{"groupId":"EG001","numAffected":316,"numAtRisk":893}],"term":"Skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":167,"numAtRisk":927},{"groupId":"EG001","numAffected":180,"numAtRisk":893}],"term":"Subcutaneous tissue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":126,"numAtRisk":927},{"groupId":"EG001","numAffected":130,"numAtRisk":893}],"term":"Radiation dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":131,"numAtRisk":927},{"groupId":"EG001","numAffected":157,"numAtRisk":893}],"term":"Muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":197,"numAtRisk":927},{"groupId":"EG001","numAffected":217,"numAtRisk":893}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":187,"numAtRisk":927},{"groupId":"EG001","numAffected":218,"numAtRisk":893}],"term":"Neuropathy-sensory"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":110,"numAtRisk":927},{"groupId":"EG001","numAffected":96,"numAtRisk":893}],"term":"Neuropathic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":283,"numAtRisk":927},{"groupId":"EG001","numAffected":256,"numAtRisk":893}],"term":"Gynecomastia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":100,"numAtRisk":927},{"groupId":"EG001","numAffected":116,"numAtRisk":893}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":118,"numAtRisk":927},{"groupId":"EG001","numAffected":150,"numAtRisk":893}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":65,"numAtRisk":927},{"groupId":"EG001","numAffected":53,"numAtRisk":893}],"term":"Hot flashes/ flushes"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":927},{"groupId":"EG001","numAffected":3,"numAtRisk":893}],"term":"Secondary Malignancy"}],"timeFrame":"10 years"}