{"eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":1,"description":"Patients receive fludarabine IV on days -5 to -2 and melphalan IV on days -3 to -2, then undergo stem cell transplantation on day 0. Patients receive cyclophosphamide on days 3 and 4, tacrolimus PO BID or IV starting on day 5, and mycophenolate mofetil IV or PO TID on days 5 to 35. Patients also receive daratumumab IV starting between days 90-150 for up to 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.\n\nAllogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic hematopoietic stem cell transplantation\n\nCyclophosphamide: Given IV\n\nDaratumumab: Given IV\n\nFludarabine: Given IV\n\nMelphalan: Given IV\n\nMycophenolate Mofetil: Given IV or PO\n\nTacrolimus: Given PO or IV","id":"EG000","otherNumAffected":1,"otherNumAtRisk":1,"seriousNumAffected":1,"seriousNumAtRisk":1,"title":"Treatment (Conditioning Regimen, Stem Cell Transplant)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Abdominal Distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Abdominal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Acidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Activated partial thromboplastin time prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Adult respiratory distress syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Agitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Alkalosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Ataxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Atelectasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Bronchial obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Bronchial stricture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Chronic Kidney Disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Cognitive disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Confusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Cytokine release syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Delirium"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Dysarthria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Edema face"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Ejection fraction decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Epstein-Barr virus infection reactivation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Esophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Forced expiratory volume decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Generalized edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Generalized muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Hallucinations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Hematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Hemolysis"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":1}],"term":"Metabolism and Nutrition Disorders"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE version 5.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":1,"numEvents":3}],"term":"Respiratory Failure"}],"timeFrame":"Adverse event information was collected for patients from baseline through study completion utilizing the CTCAE version 5.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion up to 1 year."}