{"description":"Targeted adverse events and other grade 3 or higher adverse events were collected on CRFs, regardless of attribution. The safety population EXCLUDES patients who never started protocol-assigned therapy.","eventGroups":[{"description":"Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.","id":"EG000","otherNumAffected":1293,"otherNumAtRisk":1321,"seriousNumAffected":484,"seriousNumAtRisk":1321,"title":"T+OFS"},{"description":"Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.","id":"EG001","otherNumAffected":1298,"otherNumAtRisk":1317,"seriousNumAffected":496,"seriousNumAtRisk":1317,"title":"E+OFS"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1321},{"groupId":"EG001","numAffected":4,"numAtRisk":1317}],"term":"Cardiac-ischemia/infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":446,"numAtRisk":1321},{"groupId":"EG001","numAffected":478,"numAtRisk":1317}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":807,"numAtRisk":1321},{"groupId":"EG001","numAffected":760,"numAtRisk":1317}],"term":"Fatigue (asthenia, lethargy, malaise)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":99,"numAtRisk":1321},{"groupId":"EG001","numAffected":86,"numAtRisk":1317}],"term":"Injection site reaction/extravasation changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":56,"numAtRisk":1321},{"groupId":"EG001","numAffected":60,"numAtRisk":1317}],"term":"Allergic reaction/hypersensitivity (including drug fever)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":57,"numAtRisk":1321},{"groupId":"EG001","numAffected":82,"numAtRisk":1317}],"term":"Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1321},{"groupId":"EG001","numAffected":3,"numAtRisk":1317}],"term":"Thrombosis/embolism (vascular access-related)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":1321},{"groupId":"EG001","numAffected":31,"numAtRisk":1317}],"term":"Glucose, serum-high (hyperglycemia)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":1321},{"groupId":"EG001","numAffected":17,"numAtRisk":1317}],"term":"Pancreatic endocrine: glucose intolerance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":388,"numAtRisk":1321},{"groupId":"EG001","numAffected":588,"numAtRisk":1317}],"term":"Osteoporosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":953,"numAtRisk":1321},{"groupId":"EG001","numAffected":1030,"numAtRisk":1317}],"term":"Pain - Joint"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":1321},{"groupId":"EG001","numAffected":7,"numAtRisk":1317}],"term":"Hemorrhage, CNS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1321},{"groupId":"EG001","numAffected":1,"numAtRisk":1317}],"term":"CNS cerebrovascular ischemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":738,"numAtRisk":1321},{"groupId":"EG001","numAffected":714,"numAtRisk":1317}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":486,"numAtRisk":1321},{"groupId":"EG001","numAffected":555,"numAtRisk":1317}],"term":"Libido"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":592,"numAtRisk":1321},{"groupId":"EG001","numAffected":610,"numAtRisk":1317}],"term":"Mood alteration - depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":232,"numAtRisk":1321},{"groupId":"EG001","numAffected":182,"numAtRisk":1317}],"term":"Incontinence, urinary"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":336,"numAtRisk":1321},{"groupId":"EG001","numAffected":374,"numAtRisk":1317}],"term":"Pain - Vagina"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":611,"numAtRisk":1321},{"groupId":"EG001","numAffected":683,"numAtRisk":1317}],"term":"Vaginal dryness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":752,"numAtRisk":1321},{"groupId":"EG001","numAffected":705,"numAtRisk":1317}],"term":"Sweating (diaphoresis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1081,"numAtRisk":1321},{"groupId":"EG001","numAffected":1076,"numAtRisk":1317}],"term":"Hot flashes/flushes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":179,"numAtRisk":1321},{"groupId":"EG001","numAffected":213,"numAtRisk":1317}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":0,"numAtRisk":1317}],"term":"Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":0,"numAtRisk":1317}],"term":"Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura or hemolytic uremic syndrome)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1321},{"groupId":"EG001","numAffected":1,"numAtRisk":1317}],"term":"Blood/Bone Marrow-Other (Specify)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":1,"numAtRisk":1317}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1321},{"groupId":"EG001","numAffected":2,"numAtRisk":1317}],"term":"Hemoglobin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":0,"numAtRisk":1317}],"term":"Cardiac Arrhythmia-Other (Specify)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1321},{"groupId":"EG001","numAffected":4,"numAtRisk":1317}],"term":"Cardiac-ischemia/infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1321},{"groupId":"EG001","numAffected":1,"numAtRisk":1317}],"term":"Left ventricular diastolic dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":1321},{"groupId":"EG001","numAffected":1,"numAtRisk":1317}],"term":"Left ventricular systolic dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1321},{"groupId":"EG001","numAffected":1,"numAtRisk":1317}],"term":"Pain - Cardiac/heart"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1321},{"groupId":"EG001","numAffected":2,"numAtRisk":1317}],"term":"Supraventricular and nodal arrhythmia - Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1321},{"groupId":"EG001","numAffected":0,"numAtRisk":1317}],"term":"Supraventricular and nodal arrhythmia - Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":0,"numAtRisk":1317}],"term":"Supraventricular and nodal arrhythmia - Supraventricular arrhythmia NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1321},{"groupId":"EG001","numAffected":1,"numAtRisk":1317}],"term":"Supraventricular and nodal arrhythmia - Supraventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1321},{"groupId":"EG001","numAffected":1,"numAtRisk":1317}],"term":"Valvular heart disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":1,"numAtRisk":1317}],"term":"Auditory/Ear-Other (Specify)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1321},{"groupId":"EG001","numAffected":0,"numAtRisk":1317}],"term":"Thyroid function, high (hyperthyroidism, thyrotoxicosis)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":1,"numAtRisk":1317}],"term":"Thyroid function, low (hypothyroidism)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":1,"numAtRisk":1317}],"term":"Endocrine-Other (Specify)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":1,"numAtRisk":1317}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":1,"numAtRisk":1317}],"term":"Retinal detachment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":0,"numAtRisk":1317}],"term":"Retinopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":1,"numAtRisk":1317}],"term":"Hemorrhage, GI - Rectum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":0,"numAtRisk":1317}],"term":"Hemorrhage, GI - Varices (rectal)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1321},{"groupId":"EG001","numAffected":1,"numAtRisk":1317}],"term":"Obstruction, GI - Small bowel NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":0,"numAtRisk":1317}],"term":"Perforation, GI - Duodenum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":0,"numAtRisk":1317}],"term":"Stricture/stenosis (including anastomotic), GI - Esophagus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1321},{"groupId":"EG001","numAffected":1,"numAtRisk":1317}],"term":"Ulcer, GI - Stomach"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":0,"numAtRisk":1317}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 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(Specify)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1321},{"groupId":"EG001","numAffected":0,"numAtRisk":1317}],"term":"Hemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":1321},{"groupId":"EG001","numAffected":15,"numAtRisk":1317}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":1321},{"groupId":"EG001","numAffected":3,"numAtRisk":1317}],"term":"Pain - Abdomen NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1321},{"groupId":"EG001","numAffected":2,"numAtRisk":1317}],"term":"Pain - Stomach"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":0,"numAtRisk":1317}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":1,"numAtRisk":1317}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":1321},{"groupId":"EG001","numAffected":41,"numAtRisk":1317}],"term":"Fatigue (asthenia, lethargy, malaise)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General 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(3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":0,"numAtRisk":1317}],"term":"Injection site reaction/extravasation changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1321},{"groupId":"EG001","numAffected":4,"numAtRisk":1317}],"term":"Pain - Chest/thorax NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1321},{"groupId":"EG001","numAffected":0,"numAtRisk":1317}],"term":"Pain-Other (Specify)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1321},{"groupId":"EG001","numAffected":0,"numAtRisk":1317}],"term":"Obstruction, GI - 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(3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1321},{"groupId":"EG001","numAffected":1,"numAtRisk":1317}],"term":"Pain - Gallbladder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":1321},{"groupId":"EG001","numAffected":5,"numAtRisk":1317}],"term":"Allergic reaction/hypersensitivity (including drug fever)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1321},{"groupId":"EG001","numAffected":1,"numAtRisk":1317}],"term":"Allergy/Immunology-Other (Specify)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":1321},{"groupId":"EG001","numAffected":0,"numAtRisk":1317}],"term":"Infection with normal ANC or 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(3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":0,"numAtRisk":1317}],"term":"Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":0,"numAtRisk":1317}],"term":"Apnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1321},{"groupId":"EG001","numAffected":1,"numAtRisk":1317}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":2,"numAtRisk":1317}],"term":"Dyspnea (shortness of breath)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":0,"numAtRisk":1317}],"term":"Obstruction/stenosis of airway - Larynx"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":0,"numAtRisk":1317}],"term":"Pleural effusion (non-malignant)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":1,"numAtRisk":1317}],"term":"Pneumonitis/pulmonary infiltrates"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":1,"numAtRisk":1317}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":1321},{"groupId":"EG001","numAffected":2,"numAtRisk":1317}],"term":"Pulmonary/Upper Respiratory-Other (Specify)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":1,"numAtRisk":1317}],"term":"Pruritus/itching"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":0,"numAtRisk":1317}],"term":"Rash/desquamation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":0,"numAtRisk":1317}],"term":"Skin breakdown/decubitus ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1321},{"groupId":"EG001","numAffected":1,"numAtRisk":1317}],"term":"Hematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":149,"numAtRisk":1321},{"groupId":"EG001","numAffected":127,"numAtRisk":1317}],"term":"Hot flashes/flushes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":100,"numAtRisk":1321},{"groupId":"EG001","numAffected":90,"numAtRisk":1317}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":0,"numAtRisk":1317}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1321},{"groupId":"EG001","numAffected":0,"numAtRisk":1317}],"term":"Vascular-Other (Specify)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (3.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":1321},{"groupId":"EG001","numAffected":1,"numAtRisk":1317}],"term":"Vasculitis"}],"timeFrame":"Assessed every 3 months for the first year, then every 6 months until year 6. Reported at a median follow-up of 72 months."}