{"eventGroups":[{"deathsNumAffected":4,"deathsNumAtRisk":18,"description":"Participants received intravenous daratumumab at 16 mg/kg on the same dosing schedule (weekly, every 2 weeks, or every 4 weeks of each 28-day treatment cycle) on their last prior therapy containing daratumumab regimen. The dosing schedule for daratumumab could be adjusted during the course of the study, provided the participant had a response of stable disease or better. Participants also received IV durvalumab at 1500 mg on Day 2 of Cycle 1 and then on Day 1 of Cycles ≥ 2 of each 28-day treatment cycle. Participants could continue on study treatment until progressive disease or unacceptable toxicity.","id":"EG000","otherNumAffected":17,"otherNumAtRisk":18,"seriousNumAffected":7,"seriousNumAtRisk":18,"title":"Daratumumab and Durvalumab"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":18}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":18}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Chest discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":18}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Localised oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Viral upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Amylase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":18}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Blood fibrinogen decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Lipase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18}],"term":"Hyperuricaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":18}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Pathological fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Disorientation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Catarrh"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":18}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Dyspnoea exertional"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":18}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":18}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MEDDRA V20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":18}],"term":"Pleural effusion"}],"timeFrame":"From first dose of study drug to 90 days after the last dose of daratumumab and durvalumab, whichever was later, as well as SAEs made known to the investigator at any time thereafter that are suspected of being related to daratumumab or durvalumab. Maximum overall time on treatment was 16 weeks for daratumumab and durvalumab"}