{"eventGroups":[{"deathsNumAffected":9,"deathsNumAtRisk":34,"description":"All participants will receive a conditioning regimen of Fludarabine, Melphalan and Total Body Irradiation prior to transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT)\n\nFludarabine: Fludarabine 30mg/m\\^2/day will be administered over 30-60 minutes intravenous infusion on Days -6 through -2 for a total dose of 150 mg/m\\^2\n\nMelphalan: Melphalan 70 mg/m\\^2 over 45 minutes will be administered Day -6. Melphalan dose will be calculated based on Actual Body Weight.\n\nTotal Body Irradiation: Total Body Irradiation (TBI) will be delivered at a dose of 200 centigray units (cGy)","id":"EG000","otherNumAffected":16,"otherNumAtRisk":34,"seriousNumAffected":21,"seriousNumAtRisk":34,"title":"Conditioning Regimen + Transplant"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":34,"numEvents":6}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34,"numEvents":2}],"term":"Cytomegalovirus infection reactivation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34,"numEvents":2}],"term":"Infections and infestations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34,"numEvents":2}],"term":"Lung Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Skin Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Viremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":34,"numEvents":4}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34,"numEvents":2}],"term":"Multi-organ failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Disease Progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34,"numEvents":2}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34,"numEvents":3}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":2}],"term":"Respiratory Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Respiratory, thoracic and mediastinal disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Acidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":34,"numEvents":3}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34,"numEvents":2}],"term":"Blood and lymphatic system disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34,"numEvents":2}],"term":"Immune system disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Gastrointestinal disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Generalized muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Stevens-Johnson syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Thromboembolic event"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34,"numEvents":2}],"term":"GVHD"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34,"numEvents":2}],"term":"Cytomegalovirus infection reactivation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":34,"numEvents":10}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34,"numEvents":3}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"COVID-19+"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34,"numEvents":2}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34,"numEvents":2}],"term":"Multi-organ failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Respiratory Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":34,"numEvents":3}],"term":"Blood and lymphatic system disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34,"numEvents":2}],"term":"Stevens-Johnson syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Thromboembolic event"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":34,"numEvents":5}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":2}],"term":"Bacteremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Skin and subcutaneous tissue disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34,"numEvents":2}],"term":"Viremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34,"numEvents":2}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Generalized muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Gastric hemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Hepatobiliary disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Lung Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Infections and infestations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Anaphylaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34,"numEvents":2}],"term":"Dysuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":34,"numEvents":3}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Acidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Encephalitis infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Injury, poisoning and procedural complications - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":34,"numEvents":1}],"term":"Dyspnea"}],"timeFrame":"All events beginning with start of study intervention until 30 days after the last day of study intervention (up to 36 months) will be reported."}