{"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. All-Cause Mortality includes all deaths collected on the study.","eventGroups":[{"deathsNumAffected":14,"deathsNumAtRisk":38,"description":"COURSE 1: Patients receive cytarabine IT on day 0 and at day 28-30 or up to 7 days prior to day 1 of course 2, and liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3, and 5. Patients with CNS1 receive no further CNS-directed therapy in course 1. Patients with CNS2 disease may receive additional 4-6 doses of cytarabine IT twice weekly starting 48 hours after the third dose of liposome-encapsulated daunorubicin-cytarabine until CNS is clear at the discretion of the investigator. Patients meeting criteria for CR, CRp, and CRi may proceed to course 2.\n\nCOURSE 2: Patients receive filgrastim on days 1-5 and then on day 15 until blood count recovery, and fludarabine phosphate IV over 30 minutes and high-dose cytarabine IV over 1-3 hours QD on days 1-5.","id":"EG000","otherNumAffected":34,"otherNumAtRisk":38,"seriousNumAffected":21,"seriousNumAtRisk":38,"title":"Treatment (CPX-351 and FLAG)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":38}],"term":"Blood and lymphatic system disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":38}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Ventricular arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Rectal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":38}],"term":"General disorders and administration site conditions - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Multi-organ failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":38}],"term":"Enterocolitis infectious"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":38}],"term":"Infections and infestations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":38}],"term":"Mucosal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Periorbital infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":38}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":38}],"term":"Upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":38}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":38}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":38}],"term":"Ejection fraction decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":38}],"term":"Electrocardiogram QT corrected interval prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":38}],"term":"GGT increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Investigations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":38}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":38}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":38}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Pneumothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Respiratory, thoracic and mediastinal disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":38}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Skin and subcutaneous tissue disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":38}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Gastrointestinal disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":38}],"term":"Typhlitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":38}],"term":"Death NOS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":38}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Anorectal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Catheter related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":38}],"term":"Infections and infestations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Kidney infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":38}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Small intestine infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Soft tissue infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Ejection fraction decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":38}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Nervous system disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Urinary frequency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Reproductive system and breast disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Stridor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":38}],"term":"Rash maculo-papular"}],"timeFrame":"While patients were on Protocol Therapy (up to 8 weeks) or during follow-up (up to 3 years)."}