| Anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Normocytic anaemia | Blood and lymphatic system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Acute coronary syndrome | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG0003 affected1,980 at risk
|
| Acute left ventricular failure | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Acute myocardial infarction | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG0009 affected1,980 at risk
|
| Adams-Stokes syndrome | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Angina pectoris | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG00014 affected1,980 at risk
|
| Angina unstable | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG00010 affected1,980 at risk
|
| Arrhythmia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG0004 affected1,980 at risk
|
| Atrial fibrillation | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG00014 affected1,980 at risk
|
| Atrioventricular block complete | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG0005 affected1,980 at risk
|
| Bradycardia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG0003 affected1,980 at risk
|
| Cardiac arrest | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG00013 affected1,980 at risk
|
| Cardiac failure | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG000144 affected1,980 at risk
|
| Cardiac failure acute | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG00021 affected1,980 at risk
|
| Cardiac failure chronic | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG00032 affected1,980 at risk
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG00020 affected1,980 at risk
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG0007 affected1,980 at risk
|
| Cardiogenic shock | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG0008 affected1,980 at risk
|
| Cardiorenal syndrome | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Cardiovascular disorder | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Congestive cardiomyopathy | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG0004 affected1,980 at risk
|
| Cor pulmonale | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Coronary artery disease | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Left ventricular dysfunction | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Left ventricular failure | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG0004 affected1,980 at risk
|
| Myocardial infarction | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG00016 affected1,980 at risk
|
| Myocardial ischaemia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Nodal rhythm | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Palpitations | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Sinus node dysfunction | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Systolic dysfunction | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Ventricular arrhythmia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG0005 affected1,980 at risk
|
| Ventricular fibrillation | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG0005 affected1,980 at risk
|
| Ventricular tachycardia | Cardiac disorders | MedDRA (20.1) | Systematic Assessment | | - EG00031 affected1,980 at risk
|
| Phimosis | Congenital, familial and genetic disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Vertigo | Ear and labyrinth disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Adrenal insufficiency | Endocrine disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Hypothyroidism | Endocrine disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Cataract | Eye disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Open angle glaucoma | Eye disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Refraction disorder | Eye disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0009 affected1,980 at risk
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0003 affected1,980 at risk
|
| Ascites | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Constipation | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0003 affected1,980 at risk
|
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Duodenitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Enteritis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Enterocolitis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Gastritis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Gastrointestinal angiodysplasia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Incarcerated inguinal hernia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Intestinal pseudo-obstruction | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Melaena | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Mesenteric vein thrombosis | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Pancreatic mass | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Vomiting | Gastrointestinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Asthenia | General disorders | MedDRA (20.1) | Systematic Assessment | | - EG0003 affected1,980 at risk
|
| Cardiac death | General disorders | MedDRA (20.1) | Systematic Assessment | | - EG0004 affected1,980 at risk
|
| Chest discomfort | General disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Chest pain | General disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Death | General disorders | MedDRA (20.1) | Systematic Assessment | | - EG0003 affected1,980 at risk
|
| General physical health deterioration | General disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Malaise | General disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA (20.1) | Systematic Assessment | | - EG0007 affected1,980 at risk
|
| Non-cardiac chest pain | General disorders | MedDRA (20.1) | Systematic Assessment | | - EG0004 affected1,980 at risk
|
| Oedema peripheral | General disorders | MedDRA (20.1) | Systematic Assessment | | - EG0003 affected1,980 at risk
|
| Sudden cardiac death | General disorders | MedDRA (20.1) | Systematic Assessment | | - EG00015 affected1,980 at risk
|
| Sudden death | General disorders | MedDRA (20.1) | Systematic Assessment | | - EG00013 affected1,980 at risk
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Cholangitis | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment | | - EG0003 affected1,980 at risk
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment | | - EG0003 affected1,980 at risk
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Hepatic congestion | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Hepatic failure | Hepatobiliary disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Abdominal sepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Appendicitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0003 affected1,980 at risk
|
| Arthritis bacterial | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Bacteraemia | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Bronchitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Bursitis infective | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Campylobacter gastroenteritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Cellulitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Cholecystitis infective | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Cystitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Diabetic foot infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Diarrhoea infectious | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Diverticulitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0003 affected1,980 at risk
|
| Ecthyma | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Erysipelas | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Gangrene | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0003 affected1,980 at risk
|
| Gastroenteritis | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0005 affected1,980 at risk
|
| Hepatitis E | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Hepatitis viral | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Implant site infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Infectious pleural effusion | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Influenza | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Intervertebral discitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Localised infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Lower respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0004 affected1,980 at risk
|
| Lung infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Orchitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Otitis media chronic | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Ovarian abscess | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Peritonitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0004 affected1,980 at risk
|
| Pneumococcal sepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG00047 affected1,980 at risk
|
| Postoperative wound infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Pyelonephritis acute | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0003 affected1,980 at risk
|
| Sepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG00012 affected1,980 at risk
|
| Sepsis syndrome | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Septic shock | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG00010 affected1,980 at risk
|
| Stoma site infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Streptococcal bacteraemia | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Tooth infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Tracheobronchitis | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Urinary tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG00010 affected1,980 at risk
|
| Urosepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0003 affected1,980 at risk
|
| Viral diarrhoea | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Viral infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Wound sepsis | Infections and infestations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Chest injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Electric shock | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Fall | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0005 affected1,980 at risk
|
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Fractured skull depressed | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Head injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0003 affected1,980 at risk
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Incisional hernia, obstructive | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Respiratory fume inhalation disorder | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0003 affected1,980 at risk
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Subarachnoid haemorrhage | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0003 affected1,980 at risk
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Arteriogram coronary | Investigations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Blood bilirubin increased | Investigations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Blood creatinine increased | Investigations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Blood potassium decreased | Investigations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Blood potassium increased | Investigations | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Ejection fraction abnormal | Investigations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Functional residual capacity decreased | Investigations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Hepatic enzyme increased | Investigations | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| International normalised ratio increased | Investigations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Liver function test increased | Investigations | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Weight decreased | Investigations | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment | | - EG0004 affected1,980 at risk
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment | | - EG0004 affected1,980 at risk
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Diabetic complication | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment | | - EG0003 affected1,980 at risk
|
| Rheumatic disorder | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Bladder cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Bone cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Bone cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment | | - EG0003 affected1,980 at risk
|
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment | | - EG0004 affected1,980 at risk
|
| Oesophageal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Aphasia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Brain injury | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Brain oedema | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Cerebellar infarction | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Cerebral infarction | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0006 affected1,980 at risk
|
| Cerebral ischaemia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG00013 affected1,980 at risk
|
| Cervicogenic vertigo | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Coma | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Dementia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Dizziness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0004 affected1,980 at risk
|
| Dysarthria | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Epilepsy | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Facial paralysis | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Haemorrhagic stroke | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Hemianaesthesia | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Hemiparesis | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Ischaemic stroke | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0007 affected1,980 at risk
|
| Loss of consciousness | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Post stroke seizure | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Presyncope | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Radiculopathy | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Seizure | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Syncope | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0007 affected1,980 at risk
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (20.1) | Systematic Assessment | | - EG0004 affected1,980 at risk
|
| Device battery issue | Product Issues | MedDRA (20.1) | Systematic Assessment | | - EG0003 affected1,980 at risk
|
| Device malfunction | Product Issues | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Lead dislodgement | Product Issues | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Delirium | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Depression | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Disorientation | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Mental disorder | Psychiatric disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment | | - EG00018 affected1,980 at risk
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Haematuria | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Leukocyturia | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Renal failure | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment | | - EG00012 affected1,980 at risk
|
| Renal impairment | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment | | - EG0008 affected1,980 at risk
|
| Urethral stenosis | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Urinary retention | Renal and urinary disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Acquired hydrocele | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Acquired phimosis | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Genital ulceration | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0005 affected1,980 at risk
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0003 affected1,980 at risk
|
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Bronchial oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG00010 affected1,980 at risk
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG00010 affected1,980 at risk
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0003 affected1,980 at risk
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0008 affected1,980 at risk
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0008 affected1,980 at risk
|
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Treatment noncompliance | Social circumstances | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Aortic aneurysm | Vascular disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Aortic embolus | Vascular disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Circulatory collapse | Vascular disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Deep vein thrombosis | Vascular disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Diabetic vascular disorder | Vascular disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Haematoma | Vascular disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Hypertension | Vascular disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Hypotension | Vascular disorders | MedDRA (20.1) | Systematic Assessment | | - EG00018 affected1,980 at risk
|
| Leriche syndrome | Vascular disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Orthostatic hypotension | Vascular disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (20.1) | Systematic Assessment | | - EG0002 affected1,980 at risk
|
| Peripheral artery occlusion | Vascular disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Peripheral artery stenosis | Vascular disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Peripheral artery thrombosis | Vascular disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|
| Shock | Vascular disorders | MedDRA (20.1) | Systematic Assessment | | - EG0001 affected1,980 at risk
|