{"description":"A Serious Adverse Event (SAE) is defined as: death, a life-threatening experience, hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of an exposed subject, important medical events based upon appropriate medical judgment, pregnancy.","eventGroups":[{"description":"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).\n\nLenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.\n\nDexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push.","id":"EG000","otherNumAffected":53,"otherNumAtRisk":53,"seriousNumAffected":23,"seriousNumAtRisk":53,"title":"Carfilzomib, Lenalidomide w/Dexamethasone"}],"frequencyThreshold":"5","otherEvents":[{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":53}],"term":"Hyperglycemia"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":53}],"term":"Edema"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":53}],"term":"Hypophosphatemia"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":53}],"term":"Fatigue"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":53}],"term":"Muscle Cramping"},{"organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":53}],"term":"Rash"},{"organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":53}],"term":"Elevated Liver Function Test"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":53}],"term":"Diarrhea"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":53}],"term":"Infection"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":53}],"term":"Phlebitis"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":53}],"term":"Peripheral Neuropathy"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":53}],"term":"Dyspnea"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":53}],"term":"Deep Vein Thrombosis"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":53}],"term":"Pulmonary Embolism"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":53}],"term":"Nausea"},{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":53}],"term":"Renal"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":53}],"term":"Constipation"},{"organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":53}],"term":"Mood Alterations"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":53}],"term":"Thrombocytopenia"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":53}],"term":"Anemia"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":53}],"term":"Neutropenia"}],"seriousEvents":[{"organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":53}],"term":"Acute Renal Failure"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":53}],"term":"Acute Mental Status Change"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":53}],"term":"Appendicitis"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":53}],"term":"Atrial Fibrillation"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":53}],"term":"Clostridium Difficile"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":53}],"term":"Colitis"},{"organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":53}],"term":"Compression Fracture"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":53}],"term":"Confusion"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":53}],"term":"Constipation"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":53}],"term":"Dyspnea"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":53}],"term":"Febrile Neutropenia"},{"organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":53}],"term":"Fever"},{"organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":53}],"term":"Gastroenteritis"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":53}],"term":"Grand Mal Seizure"},{"organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":53}],"term":"Hyperglycemia"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":53}],"term":"Pneumonia"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":53}],"term":"Influenza"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":53}],"term":"Anemia"},{"organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":53}],"term":"Intracranial Hemorrhage"},{"organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":53}],"term":"Methemoglobinemia"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":53}],"term":"Pulmonary Edema"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":53}],"term":"Pulmonary Toxicity"},{"organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":53}],"term":"Pulmonary Embolism"},{"organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":53}],"term":"Rapid Ventricular Response"},{"organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":53}],"term":"Seizure"},{"organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":53}],"term":"Urinary Tract Infection"}],"timeFrame":"All Adverse Events (AEs) that occurred after the subject signed consent were documented."}