Study: NCT00475852

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Angioedema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Aortic valve stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Arrhythmia supraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 3498 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 46 affected / 3498 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 3498 at risk

Adverse event: Atrial septal defect
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Atrioventricular block complete
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 3498 at risk

Adverse event: Cardiac arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 16 affected / 3498 at risk

Adverse event: Cardiac tamponade
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Pulseless electrical activity
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Endocarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Congestive hepatopathy
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Mitral valve prolapse
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Tachyarrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Ventricular arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Ventricular fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 3498 at risk

Adverse event: Ventricular septal defect
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 23 affected / 3498 at risk

Adverse event: Carcinoid tumour in the large intestine
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 5 affected / 3498 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Blindness transient
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 3498 at risk

Adverse event: Anal abscess
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Appendicitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3498 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Gastric ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 3498 at risk

Adverse event: Gastrointestinal erosion
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Gastrointestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Intestinal perforation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Device related infection
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Device related sepsis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Infusion site extravasation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Complication associated with device
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Cholecystitis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Cholecystitis acute
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Cholestasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Hepatic failure
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Hepatic function abnormal
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Hepatocellular injury
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Transfusion reaction
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Enterococcal bacteraemia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3498 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3498 at risk

Adverse event: Postoperative wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3498 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 3498 at risk

Adverse event: Staphylococcal infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 3498 at risk

Adverse event: Staphylococcal sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3498 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3498 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3498 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3498 at risk

Adverse event: Toxicity to various agents
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3498 at risk

Adverse event: Blood creatinine increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3498 at risk

Adverse event: Fibrin D dimer increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3498 at risk

Adverse event: Gastric pH decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3498 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 3498 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 3498 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Arthritis bacterial
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Hip fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Osteomyelitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Patella fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Pelvic fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 3498 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Loss of consciousness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Unresponsive to stimuli
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Acute psychosis
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Delirium
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Mental status changes
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 3498 at risk

Adverse event: Cystitis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Renal artery stenosis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Renal colic
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Ureteric haemorrhage
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Urinary tract obstruction
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Urosepsis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Benign prostatic hyperplasia
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Breast cancer
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Orchitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Acute pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Acute respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 3498 at risk

Adverse event: Bronchitis bacterial
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 3498 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 3498 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Eosinophilic pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Haemoptysis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Hypercapnia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Infective exacerbation of chronic obstructive airways disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Lower respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Lung cancer metastatic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Lung neoplasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Lung neoplasm malignant
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Mediastinum neoplasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Musculoskeletal chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 3498 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 3498 at risk

Adverse event: Pneumonia aspiration
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Pneumonia bacterial
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Pneumonia mycoplasmal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Pneumonia staphylococcal
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 3498 at risk

Adverse event: Pulmonary fibrosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Respiratory arrest
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Respiratory distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Stridor
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Acarodermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 3498 at risk

Adverse event: Dermatitis exfoliative
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Acute coronary syndrome
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Angina unstable
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Aortic dissection
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Aortic stenosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Cardiogenic shock
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 3498 at risk

Adverse event: Catheter site haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Colitis ischaemic
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 3498 at risk

Adverse event: Duodenal ulcer haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Embolic stroke
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Peripheral artery occlusion
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 3498 at risk

Adverse event: Haematemesis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Haemorrhagic stroke
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 3498 at risk

Adverse event: Haemorrhoidal haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 3498 at risk

Adverse event: Iliac artery embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Infusion site phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Ischaemic stroke
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 3498 at risk

Adverse event: Lower gastrointestinal haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 3498 at risk

Adverse event: Myocardial ischaemia
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 3498 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 3498 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Septic shock
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 3498 at risk

Adverse event: Subarachnoid haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3498 at risk

Adverse event: Syncope
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 3498 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 3498 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 3498 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 4 affected / 3509 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 3509 at risk

Adverse event: Arrhythmia supraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 3509 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 33 affected / 3509 at risk

Adverse event: Atrial flutter
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 3509 at risk

Adverse event: Atrial tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Atrioventricular block complete
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 3509 at risk

Adverse event: Cardiac arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 3509 at risk

Adverse event: Dilated cardiomyopathy
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Endocarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Ischaemic cardiomyopathy
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Mitral valve incompetence
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 3509 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Subacute endocarditis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Ventricular extrasystoles
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Ventricular fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 3509 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 30 affected / 3509 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Diabetes mellitus inadequate control
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Diabetic neuropathy
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 3509 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 8 affected / 3509 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3509 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3509 at risk

Adverse event: Diverticulum
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Faeces discoloured
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Gastric ulcer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Gastritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3509 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 3509 at risk

Adverse event: Ileus
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Pancreatitis chronic
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Rectal abscess
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Small intestinal obstruction
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Umbilical hernia, obstructive
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3509 at risk

Adverse event: Device dislocation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Hypothermia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Complication associated with device
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Sudden cardiac death
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3509 at risk

Adverse event: Sudden death
Serious: no
Organ System: General disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Cholecystitis acute
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 3509 at risk

Adverse event: Hepatic cirrhosis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Hepatic encephalopathy
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Guillain-Barre syndrome
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3509 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 3509 at risk

Adverse event: Staphylococcal bacteraemia
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 3509 at risk

Adverse event: Streptococcal sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 3509 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3509 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3509 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3509 at risk

Adverse event: Antimicrobial susceptibility test resistant
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3509 at risk

Adverse event: Blood glucose increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3509 at risk

Adverse event: Vascular access device culture positive
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3509 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3509 at risk

Adverse event: International normalised ratio increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 3509 at risk

Adverse event: Prostatic specific antigen increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 3509 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 3509 at risk

Adverse event: Gout
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3509 at risk

Adverse event: Hyperbilirubinaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 3509 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 3509 at risk

Adverse event: Hypovolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Lower limb fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Soft tissue infection
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Large intestine polyp
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3509 at risk

Adverse event: Small cell carcinoma
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3509 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 3509 at risk

Adverse event: Dyskinesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Epilepsy
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 3509 at risk

Adverse event: Alcohol withdrawal syndrome
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Failure to thrive
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 3509 at risk

Adverse event: Mental status changes
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Azotaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Bladder neoplasm
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Urinary retention
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 3509 at risk

Adverse event: Urosepsis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Endometrial cancer
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 3509 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 3509 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3509 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Idiopathic pulmonary fibrosis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Influenza
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Lung disorder
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Lung neoplasm malignant
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Mediastinitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Non-cardiac chest pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 3509 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 3509 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 3509 at risk

Adverse event: Pneumothorax
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 3509 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 3509 at risk

Adverse event: Pulmonary hypertension
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Pulmonary infarction
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3509 at risk

Adverse event: Respiratory arrest
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3509 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 3509 at risk

Adverse event: Respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3509 at risk

Adverse event: Angioedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3509 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 3509 at risk

Adverse event: Dermatitis allergic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Diabetic foot
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Diabetic foot infection
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Gangrene
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Petechiae
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Subcutaneous haematoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Abdominal wall haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 3509 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 3509 at risk

Adverse event: Angina unstable
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 3509 at risk

Adverse event: Aortic aneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Arterial haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 3509 at risk

Adverse event: Bleeding varicose vein
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Cardiogenic shock
Serious: no
Organ System: Vascular disorders
Frequency: 16 affected / 3509 at risk

Adverse event: Cerebellar haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Coronary artery disease
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 3509 at risk

Adverse event: Deep vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 3509 at risk

Adverse event: Dizziness
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 3509 at risk

Adverse event: Embolic stroke
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 3509 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Blood loss anaemia
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Haemorrhagic stroke
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 3509 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Hypertensive crisis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 3509 at risk

Adverse event: Hypoperfusion
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 3509 at risk

Adverse event: Peripheral artery thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Cardiac ventricular thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Ischaemic cerebral infarction
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Ischaemic hepatitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Ischaemic stroke
Serious: no
Organ System: Vascular disorders
Frequency: 20 affected / 3509 at risk

Adverse event: Melaena
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Myocardial infarction
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 3509 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Peptic ulcer haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Peripheral embolism
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Peripheral ischaemia
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Phlebitis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Post procedural haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 3509 at risk

Adverse event: Post procedural haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Presyncope
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 3509 at risk

Adverse event: Raynaud's phenomenon
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Rectal haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 3509 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Septic shock
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 3509 at risk

Adverse event: Shock
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Small intestinal haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Syncope
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 3509 at risk

Adverse event: Systemic inflammatory response syndrome
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Superficial vein thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 3509 at risk

Adverse event: Transient ischaemic attack
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 3509 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 3509 at risk