{"description":"The incidence of AEs was tabulated by the Medical Dictionary for Regulatory Activities (MedDRA) System Organ Class (SOC) and Preferred Term (PT), overall and by maximum Common Terminology Criteria for Adverse Events (CTCAE) grade.","eventGroups":[{"deathsNumAffected":17,"deathsNumAtRisk":38,"description":"Daratumumab:\n\nDaratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs).\n\nDexamethasone:\n\nDexamethasone was administered at 40 mg (20 mg for patients \\> 75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.","id":"EG000","otherNumAffected":32,"otherNumAtRisk":38,"seriousNumAffected":11,"seriousNumAtRisk":38,"title":"Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":38}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Haemolytic uraemic syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Leukocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":38}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Thrombotic thrombocytopenic purpura"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Atrial tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Ear pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"External ear inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":38}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Osteomyelitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":38}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":38}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":38}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":38}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":38}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":38}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":38}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":38}],"term":"Hyperuricaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":38}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":38}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Groin pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Dysphoria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":38}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Tension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":38}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Laryngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Carpal tunnel decompression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (unspecified)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":38}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (Unspecified)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Peritonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (24.1)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":38}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (24.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Eastern Cooperative Oncology Group performance status worsened"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (24.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (24.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (24.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":38}],"term":"Acute kidney injury"}],"timeFrame":"3 years."}