{"description":"ITT Analysis Set included enrolled participants who received at least one dose of study drug.","eventGroups":[{"deathsNumAffected":64,"deathsNumAtRisk":125,"description":"Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.","id":"EG000","otherNumAffected":123,"otherNumAtRisk":125,"seriousNumAffected":72,"seriousNumAtRisk":125,"title":"Idelalisib"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":125}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":125}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":125}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":125}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":125}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":125}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":125}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":59,"numAtRisk":125}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":125}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":125}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":125}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":125}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":125}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":125}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":125}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":125}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":125}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":125}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":125}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":125}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":125}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":125}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":125}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":125}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":125}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":125}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":125}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":125}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":125}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":125}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":125}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":125}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":125}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":125}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":125}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":125}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":125}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":125}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":125}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":125}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":40,"numAtRisk":125}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":125}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":125}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":125}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":125}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":125}],"term":"Night sweats"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":125}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":125}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":125}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":125}],"term":"Hypotension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":125}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Autoimmune haemolytic anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":125}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":125}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Splenic infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":125}],"term":"Cardiac failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Cardiomyopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Supraventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Visual impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Acute abdomen"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Autoimmune colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":125}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":125}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Enteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":125}],"term":"Melaena"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Mouth haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Oesophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Rectal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":125}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":125}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":125}],"term":"Chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":125}],"term":"Multiple organ dysfunction syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":125}],"term":"Peripheral swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":125}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Cholelithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Hepatic function abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Anaphylactic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Autoimmune disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":125}],"term":"Cytomegalovirus colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":125}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Infective exacerbation of chronic obstructive airways disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":125}],"term":"Perirectal abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Pharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":125}],"term":"Pneumocystis jirovecii pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":125}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Pneumonia cytomegaloviral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Pneumonia necrotising"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Pneumonia pneumococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Pneumonia pseudomonal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Pneumonia staphylococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Pneumonia streptococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":125}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Sepsis syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":125}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Soft tissue infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Staphylococcal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Toxoplasmosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":125}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Varicella zoster virus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Head injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Hip fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Limb injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":125}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Failure to thrive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":125}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":125}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Metabolic acidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Adenocarcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Basal cell carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Gastric cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Skin cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":125}],"term":"Squamous cell carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Cerebral ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Paraplegia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":125}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Hydronephrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":125}],"term":"Acute respiratory distress syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":125}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Interstitial lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Lung infiltration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":125}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":125}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":125}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Dermatitis exfoliative generalised"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":125}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 21.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":125}],"term":"Lymphorrhoea"}],"timeFrame":"Adverse Events: Start of Treatment to End of Treatment (up to 81 months) plus 30 days; All-Cause Mortality: Baseline to Last Long-Term Follow-Up Visit (up to maximum of 7 years)"}