| Anaemia | Blood and lymphatic system disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0002 events2 affected896 at risk
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Acute coronary syndrome | Cardiac disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Atrial fibrillation | Cardiac disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Atrial flutter | Cardiac disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0002 events2 affected896 at risk
|
| Atrioventricular block | Cardiac disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Bradycardia | Cardiac disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0003 events2 affected896 at risk
|
| Cardiac arrest | Cardiac disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Cardiac failure congestive | Cardiac disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0002 events2 affected896 at risk
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Myocardial infarction | Cardiac disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Pericardial effusion | Cardiac disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Sick sinus syndrome | Cardiac disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Hydrocele | Congenital, familial and genetic disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Colitis microscopic | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0002 events2 affected896 at risk
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Faecaloma | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Gastritis | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Nausea | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Pancreatitis | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Chest pain | General disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0004 events4 affected896 at risk
|
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0002 events2 affected896 at risk
|
| Hypersensitivity | Immune system disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Appendicitis | Infections and infestations | MedDRA Version 16.0 | Systematic Assessment | | - EG0003 events3 affected896 at risk
|
| Bacterial pyelonephritis | Infections and infestations | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Bronchitis | Infections and infestations | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Cellulitis | Infections and infestations | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Cholecystitis infective | Infections and infestations | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Clostridium difficile infection | Infections and infestations | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Lower respiratory tract infection | Infections and infestations | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Pneumonia | Infections and infestations | MedDRA Version 16.0 | Systematic Assessment | | - EG0006 events6 affected896 at risk
|
| Sepsis | Infections and infestations | MedDRA Version 16.0 | Systematic Assessment | | - EG0005 events4 affected896 at risk
|
| Urinary tract infection | Infections and infestations | MedDRA Version 16.0 | Systematic Assessment | | - EG00011 events11 affected896 at risk
|
| Urosepsis | Infections and infestations | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Concussion | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Fall | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Systematic Assessment | | - EG0009 events9 affected896 at risk
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Systematic Assessment | | - EG0002 events2 affected896 at risk
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Systematic Assessment | | - EG0002 events2 affected896 at risk
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Overdose | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Pulmonary contusion | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Blood glucose increased | Investigations | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Liver function test abnormal | Investigations | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Weight decreased | Investigations | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0004 events4 affected896 at risk
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0002 events2 affected896 at risk
|
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Breast cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Tonsil cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Altered state of consciousness | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0002 events2 affected896 at risk
|
| Coordination abnormal | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Dementia | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Dementia Alzheimer's type | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0003 events3 affected896 at risk
|
| Grand mal convlusion | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Headache | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Ischaemic stroke | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Lacunar infarction | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Loss of consciousness | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0002 events2 affected896 at risk
|
| Migraine | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Presyncope | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Seizure like phenomena | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Serotonin syndrome | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Syncope | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0007 events6 affected896 at risk
|
| Transient ischaemic attack | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0004 events4 affected896 at risk
|
| Tremor | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| VIIth nerve paralysis | Nervous system disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Abnormal behavior | Psychiatric disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Aggression | Psychiatric disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0003 events3 affected896 at risk
|
| Agitation | Psychiatric disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0004 events4 affected896 at risk
|
| Confusional state | Psychiatric disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Delirium | Psychiatric disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0003 events3 affected896 at risk
|
| Hallucination, visual | Psychiatric disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Hypersexuality | Psychiatric disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Mental status changes | Psychiatric disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0004 events3 affected896 at risk
|
| Staring | Psychiatric disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Suicidal ideation | Psychiatric disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0003 events3 affected896 at risk
|
| Suicidal attempt | Psychiatric disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Bladder mass | Renal and urinary disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Bladder prolapse | Renal and urinary disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Cystitis noninfective | Renal and urinary disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Haematuria | Renal and urinary disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0002 events2 affected896 at risk
|
| Nephropathy | Renal and urinary disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Renal failure, acute | Renal and urinary disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0002 events2 affected896 at risk
|
| Renal impairment | Renal and urinary disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Urinary tract obstruction | Renal and urinary disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Uterine prolapse | Reproductive system and breast disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0002 events2 affected896 at risk
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0004 events4 affected896 at risk
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0002 events1 affected896 at risk
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0003 events3 affected896 at risk
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Circulatory collapse | Vascular disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0003 events2 affected896 at risk
|
| Deep vein thrombosis | Vascular disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Hypertensive crisis | Vascular disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Hypotension | Vascular disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|
| Orthostatic hypotension | Vascular disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0002 events2 affected896 at risk
|
| Thrombosis | Vascular disorders | MedDRA Version 16.0 | Systematic Assessment | | - EG0001 events1 affected896 at risk
|