{"description":"55 patients were enrolled. 3 patients did not undergo treatment. Only 52 patients were evaluable for toxicity.","eventGroups":[{"description":"Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.","id":"EG000","otherNumAffected":25,"otherNumAtRisk":52,"seriousNumAffected":7,"seriousNumAtRisk":52,"title":"Treatment (Soy Isoflavones)"}],"frequencyThreshold":"0","otherEvents":[{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":24}],"term":"Hemoglobin"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Leukocytes (total WBC)"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":4}],"term":"Lymphopenia"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Platelets"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52,"numEvents":5}],"term":"Fatigue (asthenia, lethargy, malaise)"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":2}],"term":"Fever in the absence of neutropenia"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Sweating (diaphoresis)"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52,"numEvents":5}],"term":"Weight gain"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":4}],"term":"Weight loss"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Dermatology/Skin - Other"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Flushing"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Anorexia"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":2}],"term":"Constipation"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":2}],"term":"Diarrhea"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Dysphagia (difficulty swallowing)"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52,"numEvents":4}],"term":"Nausea"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Vomiting"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Hemorrhage, Esophagus"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Hemorrhage, Oral Cavity"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Infection, Blood"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Infection, Neck NOS"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Infection - Other"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Infection, Skin (cellulitis)"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":2}],"term":"Edema: head and neck"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":3}],"term":"Edema: limb"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"AST, SGOT(serum glutamic oxaloacetic transaminase)"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52,"numEvents":6}],"term":"Albumin, serum-low (hypoalbuminemia)"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":4}],"term":"Amylase"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Bilirubin (hyperbilirubinemia)"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":4}],"term":"Calcium, serum-high (hypercalcemia)"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":52,"numEvents":11}],"term":"Calcium, serum-low (hypocalcemia)"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":4}],"term":"Cholesterol, serum-high (hypercholestremia)"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":2}],"term":"Creatinine"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":52,"numEvents":19}],"term":"Glucose, serum-high (hyperglycemia)"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52,"numEvents":5}],"term":"Lipase"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":6}],"term":"Magnesium, serum-high (hypermagnesemia)"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52,"numEvents":6}],"term":"Magnesium, serum-low (hypomagnesemia)"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":7}],"term":"Phosphate, serum-low (hypophosphatemia)"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":2}],"term":"Potassium, serum-high (hyperkalemia)"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":5}],"term":"Potassium, serum-low (hypokalemia)"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":2}],"term":"Sodium, serum-high (hypernatremia)"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52,"numEvents":6}],"term":"Sodium, serum-low (hyponatremia)"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":52,"numEvents":10}],"term":"Triglyceride, serum-high (hypertriglyceridemia)"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Extremity-upper (function)"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Joint-function"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Muscle weakness, Extraocular"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Muscle weakness, facial"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Muscle weakness, Whole Body"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Musculoskeletal/Soft Tissue - Other"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":2}],"term":"Confusion"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Mood alteration, Depression"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Neurology - Other"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Neuropathy: sensory"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":3}],"term":"Pain, Abdomen NOS"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Pain, Back"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Pain, Face"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Pain, Head"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Pain, Neck"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52,"numEvents":4}],"term":"Pain, Oral"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Pain, Throat"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Pain - Other"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Aspiration"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Bronchospasm, wheezing"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":2}],"term":"Cough"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Hypoxia"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":2}],"term":"Urinary retention (including neurogenic bladder)"},{"organSystem":"Surgical and medical procedures","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Intra-operative injury"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Syndromes - Other"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Vessel injury-vein"}],"seriousEvents":[{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Cardiopulmonary arrest, cause unknown (non-fatal)"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Nausea"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Infection, Lung"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Infection, Wound"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Pain, Bone"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Pulmonary/Upper Respiratory - Other"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1}],"term":"Acute Respiratory Distress Syndrome"}]}