{"eventGroups":[{"deathsNumAffected":4,"deathsNumAtRisk":80,"description":"Participants received intravenous infusion of moxetumomab pasudotox 40 µg/kg on Days 1, 3, and 5 of each 28-day cycle for up to 6 cycles, until documentation of complete response, progressive disease, initiation of alternate therapy, or unacceptable toxicity.","id":"EG000","otherNumAffected":77,"otherNumAtRisk":80,"seriousNumAffected":28,"seriousNumAtRisk":80,"title":"Moxetumomab Pasudotox 40 µg/kg"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":80,"numEvents":41}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":80,"numEvents":5}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":80,"numEvents":6}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":80,"numEvents":4}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":80,"numEvents":6}],"term":"Dry eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":80,"numEvents":8}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":80,"numEvents":12}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":80,"numEvents":7}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":80,"numEvents":5}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":80,"numEvents":21}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":80,"numEvents":20}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":80,"numEvents":5}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":80,"numEvents":5}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":80,"numEvents":48}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":80,"numEvents":17}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":80,"numEvents":30}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":80,"numEvents":18}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":80,"numEvents":16}],"term":"Face oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":80,"numEvents":40}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":80,"numEvents":4}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":80,"numEvents":5}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":80,"numEvents":47}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":80,"numEvents":5}],"term":"Peripheral swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":80,"numEvents":35}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":80,"numEvents":4}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":80,"numEvents":4}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":80,"numEvents":4}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":80,"numEvents":5}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":80,"numEvents":6}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":80,"numEvents":43}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":80,"numEvents":38}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":80,"numEvents":8}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":80,"numEvents":14}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":80,"numEvents":15}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":80,"numEvents":6}],"term":"Haptoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":80,"numEvents":73}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":80,"numEvents":10}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":80,"numEvents":18}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":80,"numEvents":7}],"term":"Weight increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":80,"numEvents":15}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":80,"numEvents":12}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":80,"numEvents":15}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":80,"numEvents":8}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":80,"numEvents":5}],"term":"Hypernatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":80,"numEvents":51}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":80,"numEvents":39}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":80,"numEvents":22}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":80,"numEvents":8}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":80,"numEvents":17}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":80,"numEvents":47}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":80,"numEvents":22}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":80,"numEvents":12}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":80,"numEvents":4}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":80,"numEvents":7}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":80,"numEvents":16}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":80,"numEvents":14}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":80,"numEvents":12}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":80,"numEvents":5}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":80,"numEvents":37}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":80,"numEvents":8}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":80,"numEvents":9}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":80,"numEvents":9}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":80,"numEvents":5}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":80,"numEvents":8}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":80,"numEvents":10}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":80,"numEvents":5}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":80,"numEvents":8}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":80,"numEvents":6}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":80,"numEvents":12}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":80,"numEvents":4}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":80,"numEvents":5}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":80,"numEvents":4}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":80,"numEvents":38}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":80,"numEvents":8}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":80,"numEvents":3}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":80,"numEvents":6}],"term":"Haemolytic uraemic syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Left ventricular dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Neutropenic colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Multiple organ dysfunction syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":80,"numEvents":5}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Clostridium difficile colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Erysipelas"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Pneumonia fungal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Sepsis syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":80,"numEvents":2}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":80,"numEvents":2}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Haptoglobin decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Weight increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Rhabdomyolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Glioblastoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Mental status changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":80,"numEvents":2}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Pharyngeal cyst"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Tachypnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":80,"numEvents":1}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 19.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":80,"numEvents":5}],"term":"Capillary leak syndrome"}],"timeFrame":"For TEAEs and TESAEs: From the start of study treatment (Day 1) through 4-6 weeks after last dose of Cycle 6 (28-day cycle) (approximately 7 months) All-cause mortality data: From the start of study treatment (Day 1) through end of study (approximately 6 years)"}