{"description":"Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The \"AE Other\" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.","eventGroups":[{"deathsNumAffected":76,"deathsNumAtRisk":253,"description":"Patients receive caspofungin acetate IV over one hour QD beginning within 24-72 hours following the last dose of chemotherapy for each course. and continuing until ANC \\> 100-500/uL following the nadir or the next chemotherapy course begins.\n\nCaspofungin Acetate: Given IV\n\nLaboratory Biomarker Analysis: Correlative studies","id":"EG000","otherNumAffected":62,"otherNumAtRisk":253,"seriousNumAffected":11,"seriousNumAtRisk":253,"title":"Arm I (Caspofungin Acetate)"},{"deathsNumAffected":82,"deathsNumAtRisk":255,"description":"Patients receive fluconazole IV over 1-2 hours or PO QD beginning within 24-72 hours following the last dose of chemotherapy for each course.\n\nFluconazole: Given IV or PO\n\nLaboratory Biomarker Analysis: Correlative studies","id":"EG001","otherNumAffected":72,"otherNumAtRisk":255,"seriousNumAffected":9,"seriousNumAtRisk":255,"title":"Arm II (Fluconazole)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":253},{"groupId":"EG001","numAffected":3,"numAtRisk":255}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":4,"numAtRisk":255}],"term":"Adult respiratory distress syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":253},{"groupId":"EG001","numAffected":9,"numAtRisk":255}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":0,"numAtRisk":255}],"term":"Allergic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":253},{"groupId":"EG001","numAffected":0,"numAtRisk":255}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Appendicitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":7,"numAtRisk":255}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Atelectasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":3,"numAtRisk":255}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Catheter related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":0,"numAtRisk":255}],"term":"Cytokine release syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":0,"numAtRisk":255}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Ejection fraction decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Electrocardiogram QT corrected interval prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":0,"numAtRisk":255}],"term":"Encephalitis infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":0,"numAtRisk":255}],"term":"Encephalomyelitis infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":0,"numAtRisk":255}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Enterocolitis infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":253},{"groupId":"EG001","numAffected":2,"numAtRisk":255}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":2,"numAtRisk":255}],"term":"GGT increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":253},{"groupId":"EG001","numAffected":4,"numAtRisk":255}],"term":"Heart failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Hepatic failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":0,"numAtRisk":255}],"term":"Hydrocephalus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":3,"numAtRisk":255}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":253},{"groupId":"EG001","numAffected":0,"numAtRisk":255}],"term":"Hypernatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":253},{"groupId":"EG001","numAffected":4,"numAtRisk":255}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Hypoglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":253},{"groupId":"EG001","numAffected":11,"numAtRisk":255}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":0,"numAtRisk":255}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":253},{"groupId":"EG001","numAffected":3,"numAtRisk":255}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":253},{"groupId":"EG001","numAffected":12,"numAtRisk":255}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":253},{"groupId":"EG001","numAffected":4,"numAtRisk":255}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Immune system disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":253},{"groupId":"EG001","numAffected":9,"numAtRisk":255}],"term":"Infections and infestations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":0,"numAtRisk":255}],"term":"Investigations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":3,"numAtRisk":255}],"term":"Left ventricular systolic dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Lipase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":253},{"groupId":"EG001","numAffected":2,"numAtRisk":255}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":3,"numAtRisk":255}],"term":"Multi-organ failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Peritoneal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Pulmonary edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":253},{"groupId":"EG001","numAffected":8,"numAtRisk":255}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Right ventricular dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Salivary gland infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":253},{"groupId":"EG001","numAffected":43,"numAtRisk":255}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":0,"numAtRisk":255}],"term":"Skin and subcutaneous tissue disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":0,"numAtRisk":255}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Soft tissue infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"Soft tissue necrosis lower limb"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":0,"numAtRisk":255}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":253},{"groupId":"EG001","numAffected":2,"numAtRisk":255}],"term":"Typhlitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":0,"numAtRisk":255}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":253},{"groupId":"EG001","numAffected":1,"numAtRisk":255}],"term":"White blood cell decreased"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":0,"numAtRisk":255}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE v4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":253},{"groupId":"EG001","numAffected":0,"numAtRisk":255}],"term":"Alanine aminotransferase 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