{"eventGroups":[{"description":"The patients received Volasertib 200 mg administered by Intravenous Infusion (IV) over 60 minutes on Day 1 and Day 15 of 28-day and Azacitidine 75 mg/m\\^2 administered by subcutaneous injection on days 1-7 of 28 day treatment cycle.","id":"EG000","otherNumAffected":5,"otherNumAtRisk":5,"seriousNumAffected":2,"seriousNumAtRisk":5,"title":"Volasertib 200 mg"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Eyelids pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Tongue coated"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":5}],"term":"Injection site reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Peripheral swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Hepatic function abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system 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increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Blood creatine phosphokinase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Haemoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Iron overload"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Renal impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Drug eruption"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Purpura"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Disseminated intravascular coagulation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Pyelonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 18.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Acute kidney injury"}],"timeFrame":"From first drug administration until 30 days after last trial drug administration in the last treatment cycle or the decision of study treatment discontinuation, whichever is later, and was up to 389 days."}