Study: NCT00997503

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 253 affected / 4199 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 100 affected / 4199 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 77 affected / 4199 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 48 affected / 4199 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 50 affected / 4199 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 46 affected / 4199 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 45 affected / 4199 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 22 affected / 4199 at risk

Adverse event: Coronary artery thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 21 affected / 4199 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 4199 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 4199 at risk

Adverse event: Coronary artery dissection
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 4199 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 4199 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 4199 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 4199 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 4199 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 4199 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 4199 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 4199 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 4199 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 4199 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 4199 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4199 at risk

Adverse event: Cardiac failure chronic
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4199 at risk

Adverse event: Cardiorespiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4199 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4199 at risk

Adverse event: Congestive myopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4199 at risk

Adverse event: Left ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4199 at risk

Adverse event: Arteriospasm coronary
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Coronary artery perforation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Palpitations
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Aortic valve stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Atrial tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Atrioventricular block first degree
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Cardiac aneurysm
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Cardiac disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Cardiopulmonary failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Conduction disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Hypertensive heart disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Hypertrophic cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Microvascular coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Pericarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Postural orthostatic tachycardia syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Stress cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Ventricle rupture
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Ventricular dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 160 affected / 4199 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 20 affected / 4199 at risk

Adverse event: Catheter site haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 4199 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 4199 at risk

Adverse event: Catheter site haematoma
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 4199 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 4199 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 4199 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Impaired healing
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Catheter site discharge
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Catheter site pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 4199 at risk

Adverse event: Rectal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 4199 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 4199 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 4199 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 4199 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 4199 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4199 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 4199 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 4199 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 4199 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 4199 at risk

Adverse event: Haematemesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 4199 at risk

Adverse event: Gastritis haemorrhagic
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 4199 at risk

Adverse event: Peptic ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4199 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Diabetic gastroparesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Duodenal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Gastritis erosive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Haemorrhoidal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Impaired gastric emptying
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Retroperitoneal haematoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Abdominal pain lower
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Colitis ulcerative
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Diverticulum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Diverticulum intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Duodenal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Entercolitis haemorrhagic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Gastric ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Gastrointestinal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Gastrointestinal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Hiatus hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Ileus paralytic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Intra-abdominal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Lip haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Intra-abdominal fluid collection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Mallory-Weiss syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Melaena
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Obstruction gastric
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Oesophageal rupture
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Oesophageal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Oesophageal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Oesophageal varices haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Pancreatic cyst
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Pancreatic pseudocyst
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Pacreatitis chronic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Peptic ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Peptic ulcer perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Haemoperitoneum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Proctitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Rectal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Small intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 29 affected / 4199 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 4199 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 4199 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 4199 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 4199 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4199 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 4199 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4199 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 4199 at risk

Adverse event: Cellulitis staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4199 at risk

Adverse event: Diabetic foot infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4199 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4199 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4199 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4199 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4199 at risk

Adverse event: Pneumonia staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4199 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4199 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4199 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4199 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4199 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 4199 at risk

Adverse event: Abdominal wall access
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4199 at risk

Adverse event: Abdominal wall infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4199 at risk

Adverse event: Abscess intestinal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4199 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4199 at risk

Adverse event: Bronchopulmonary aspergillosis allergic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4199 at risk

Adverse event: Device related infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4199 at risk

Adverse event: Empyema
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4199 at risk

Adverse event: Fungal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4199 at risk

Adverse event: Groin infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4199 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4199 at risk

Adverse event: Infected lymphocyle
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4199 at risk

Adverse event: Infected skin ulcer
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4199 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4199 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4199 at risk

Adverse event: Pneumonia pneumococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4199 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4199 at risk

Adverse event: Rectal abcess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4199 at risk

Adverse event: Scrotal abcess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4199 at risk

Adverse event: Sepsis syndrome
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4199 at risk

Adverse event: Staphylococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4199 at risk

Adverse event: Steptococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4199 at risk

Adverse event: Thrombophlebitis septic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4199 at risk

Adverse event: Tracheobronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4199 at risk

Adverse event: Upper respiritory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 4199 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 20 affected / 4199 at risk

Adverse event: Carotic artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 13 affected / 4199 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 11 affected / 4199 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 8 affected / 4199 at risk

Adverse event: Presyncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 6 affected / 4199 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 4199 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 4199 at risk

Adverse event: Embolic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 4199 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 4199 at risk

Adverse event: Carotid sinus syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Amnesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Basilar artery thrombosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Brain stem infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Burning sensation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Carotic artery occlusion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Cervicobrachial syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Facial paralysis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Guillain-Barre syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Hemianopia homonymous
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Hepatic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Hypertensive encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Lacunar infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Lumbar radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Rapiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Tarsal tunnel syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Thrombotic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Transient global amnesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Vertobasilar insufficiency
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 4199 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 4199 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 4199 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 4199 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 4199 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 4199 at risk

Adverse event: Aortic stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 4199 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 4199 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 4199 at risk

Adverse event: Iliac artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 4199 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 4199 at risk

Adverse event: Peripheral artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 4199 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Malignant hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Peripheral artery aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Vasospasm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Arterial fibrosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Arterial haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Arterial stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Peripheral artery thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Arteriosclerosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Blue toe syndrome
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Iliac artery occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Peripheral artery dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Subclavian artery stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Venous stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Chronic obstruction pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 4199 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 4199 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 4199 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 4199 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 4199 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 4199 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Acute pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Pleuritic pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Bronchitis chronic
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Lung infiltration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Pleurisy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Pulmonary alveolar haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Pulmonary fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Respiratory arrest
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Asthmatic crisis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 16 affected / 4199 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 4199 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 4199 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 4199 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 4199 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 4199 at risk

Adverse event: Post procedural myocardial infarction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 4199 at risk

Adverse event: Anaemia postoperative
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4199 at risk

Adverse event: Device malfunction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4199 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4199 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4199 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4199 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4199 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 4199 at risk

Adverse event: Anastamotic ulcer haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Burns third degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Contrast media reaction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Device lead damage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Craniofacial fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Fibula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Incision site haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Incision site pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Incisional hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Joint injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Mouth injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Post procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Scrotal haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Skin laceration
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Splenic rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Traumatic lung injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Vascular procedure complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 27 affected / 4199 at risk

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 4199 at risk

Adverse event: Microcytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Normochromic normocytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Thrombocytopenic purpura
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Anaemic haemolytic autoimmune
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Heparin-induced thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Leukocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Platelet aggregation inhibition
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 17 affected / 4199 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 4199 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 6 affected / 4199 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 4199 at risk

Adverse event: Renal artery stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 4199 at risk

Adverse event: Nephrotic syndrome
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Pelvi-ureteric obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Renal impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Cystitis haemorrhagic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Urethral haemorrhagic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 4199 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 4199 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 4199 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 4199 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 4199 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Costochondritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Muscular weakness
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Rotator cuff syndrome
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Arthrofibrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Bursitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Cervical spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Lumbar spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Spinal osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Spondylolisthesis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Systemic lupus erythematosus
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 4199 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 3 affected / 4199 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4199 at risk

Adverse event: Bladder transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4199 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4199 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4199 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 4199 at risk

Adverse event: Benign neoplasm of bladder
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4199 at risk

Adverse event: Gastrointestinal cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4199 at risk

Adverse event: Hepatic cancer stage IV
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4199 at risk

Adverse event: Intestinal adenocarcenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4199 at risk

Adverse event: Leukaemia recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4199 at risk

Adverse event: Lung adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4199 at risk

Adverse event: Lung adenocarcinoma stage IV
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4199 at risk

Adverse event: Lung squamous cell carcinoma stage 1
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4199 at risk

Adverse event: Lung squamous cell carcinoma stage III
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4199 at risk

Adverse event: Squamous cell carcinoma of lung
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4199 at risk

Adverse event: Metastases to liver
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4199 at risk

Adverse event: Plasma cell myeloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4199 at risk

Adverse event: Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4199 at risk

Adverse event: Non-small cell lung cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4199 at risk

Adverse event: Oesophageal adenocarcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4199 at risk

Adverse event: Oesophageal carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4199 at risk

Adverse event: Pharyngeal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4199 at risk

Adverse event: Prostate cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4199 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4199 at risk

Adverse event: Rectal cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4199 at risk

Adverse event: Renal cancer carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4199 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4199 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4199 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4199 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 4199 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Type 2 diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Hypomagnesaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Obesity
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Vitamin D deficiency
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 7 affected / 4199 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 4199 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 4199 at risk

Adverse event: Biliary dyskinesia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Biliary obstruction
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Bile duct stenosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Gallbladder disorder
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Mental status changes
Serious: yes
Organ System: Psychiatric disorders
Frequency: 5 affected / 4199 at risk

Adverse event: Alcohol withdrawal syndrome
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Myocardial necrosis marker increased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 4199 at risk

Adverse event: Haemoglobin decreased
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 4199 at risk

Adverse event: Bacterial test positive
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4199 at risk

Adverse event: Blood glucose decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4199 at risk

Adverse event: Cardiac stress test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4199 at risk

Adverse event: Electrocardiogram abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4199 at risk

Adverse event: Troponin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 4199 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 4 affected / 4199 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 4199 at risk

Adverse event: Heavy menstrual bleeding
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 4199 at risk

Adverse event: Uterine prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Vaginal prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Haemorrhagic arteriovenous malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Stevens-Johnson syndrome
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Retinal artery occlusion
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Primary hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Blood loss anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 4199 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 43 affected / 4199 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Cardiac disorders
Frequency: 21 affected / 4199 at risk

Adverse event: Coronary artery dissection
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 4199 at risk

Adverse event: Acute myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Angina unstable
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Coronary artery stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Coronary artery thrombosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 47 affected / 4199 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 4199 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 4199 at risk

Adverse event: Gingival bleeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 4199 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4199 at risk

Adverse event: Haematochezia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4199 at risk

Adverse event: Melaena
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 4199 at risk

Adverse event: Faeces discoloured
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Gastric ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Haemorrhoidal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Adverse drug reaction
Serious: no
Organ System: General disorders
Frequency: 20 affected / 4199 at risk

Adverse event: Catheter site haematoma
Serious: no
Organ System: General disorders
Frequency: 7 affected / 4199 at risk

Adverse event: Catheter site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Catheter site discharge
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Catheter site related reaction
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Puncture site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Post-procedure myocardial infarction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 4199 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 4199 at risk

Adverse event: Animal scratch
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Limb injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Post procedural haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Subdural haematoma
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Tongue injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Vascular procedure complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Vascular pseudoaneurysm
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Venous injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4199 at risk

Adverse event: Drug hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 19 affected / 4199 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 4199 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 4199 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 4199 at risk

Adverse event: Arteriovenous fistula
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Venous stenosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Myocardial necrosis marker increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 4199 at risk

Adverse event: Troponin increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 4199 at risk

Adverse event: Bleeding time prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4199 at risk

Adverse event: Blood creatine phosphokinase MB increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4199 at risk

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4199 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 10 affected / 4199 at risk

Adverse event: Haemorrhage urinary tract
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Nephrolithiasis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 4199 at risk

Adverse event: Skin haemorrhage
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Rash erythematous
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Rash generalise
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 4199 at risk

Adverse event: Iron deficiency anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Ischaemic stroke
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 4199 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Hyphaema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Joint effusion
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Haematospermia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Heavy menstrual bleeding
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Scrotal haematocoele
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 4199 at risk

Adverse event: Bladder cancer recurrent
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 4199 at risk