{"description":"We used the standard definition of adverse events. Only grade 3-4 adverse events were tracked and reported. Grade 3 \\& 4 AEs are listed in the 'other non-serious' adverse events as they were documented. They did not meet the definition of serious therefore are listed in the separate category.","eventGroups":[{"deathsNumAffected":8,"deathsNumAtRisk":25,"description":"All patients will receive a haploidentical donor transplant using a conditioning regimen of Fludarabine (Flu), cyclophosphamide (cy) and total body irradiation (TBI) followed by MLN9708.\n\nMLN9708: MLN9708 will be given weekly x 3 weeks every 28 day cycles, for up to 12 cycles starting at D+5 post-transplant.","id":"EG000","otherNumAffected":22,"otherNumAtRisk":25,"seriousNumAffected":10,"seriousNumAtRisk":25,"title":"Haploidentical Transplant"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":25,"numEvents":7}],"term":"Graft versus host disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":25,"numEvents":8}],"term":"Skin rash with or without pruritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":25,"numEvents":8}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":25,"numEvents":4}],"term":"Elevated AST"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":25,"numEvents":7}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":25,"numEvents":4}],"term":"Hyperglycemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":25,"numEvents":3}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":25,"numEvents":5}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2}],"term":"Syncope"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2}],"term":"Hypokalemia"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":25,"numEvents":15}],"term":"Fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2}],"term":"Nausea & vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Edema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Hernia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2}],"term":"Graft Versus Host Disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"DIarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":25,"numEvents":3}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Bacteremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Dysuria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Spinal cord compression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Thrombotic microangiopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2}],"term":"Acute Renal Failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Acute Respiratory Failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Hypoxia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Vasculitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"HHV6 infection"}],"timeFrame":"Adverse Events were collected from the first dose of study drug through 30 days after administration of the last dose of MLN9708."}