Study: NCT03400033

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 270 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 270 at risk

Adverse event: Arteriovenous fistula site infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 270 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 270 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 270 at risk

Adverse event: Acinetobacter infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Atypical pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Campylobacter colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Ear infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Enteritis infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Enterococcal bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: H1N1 influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Injection site cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Prostatitis Escherichia coli
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Proteus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Pseudomembranous colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Skin bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Tubo-ovarian abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Arteriovenous fistula thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 270 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 270 at risk

Adverse event: Arteriovenous fistula site complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 270 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 270 at risk

Adverse event: Vascular graft occlusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 270 at risk

Adverse event: Arteriovenous fistula site haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 270 at risk

Adverse event: Arteriovenous fistula site haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 270 at risk

Adverse event: Arthropod bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 270 at risk

Adverse event: Multiple fractures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 270 at risk

Adverse event: Rib fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 270 at risk

Adverse event: Sternal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 270 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 270 at risk

Adverse event: Vascular access site thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 270 at risk

Adverse event: Vascular access site pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 270 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 270 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 270 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 270 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 270 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 270 at risk

Adverse event: Extremity necrosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 270 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 270 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 270 at risk

Adverse event: Arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 270 at risk

Adverse event: Brachiocephalic vein stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 270 at risk

Adverse event: Dialysis induced hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 270 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 270 at risk

Adverse event: Malignant hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 270 at risk

Adverse event: Orthostatic hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 270 at risk

Adverse event: Subclavian vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 270 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 270 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 270 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 270 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 270 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 270 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 270 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 270 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 270 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 270 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 270 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 270 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 270 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 270 at risk

Adverse event: Hypertensive encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 270 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 270 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 270 at risk

Adverse event: Myoclonus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 270 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 270 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 270 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 270 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 270 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 270 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 270 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 270 at risk

Adverse event: Chronic gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 270 at risk

Adverse event: Diabetic gastroparesis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 270 at risk

Adverse event: Gastric antral vascular ectasia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 270 at risk

Adverse event: Gastric dilatation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 270 at risk

Adverse event: Gastric ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 270 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 270 at risk

Adverse event: Pancreatitis relapsing
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 270 at risk

Adverse event: Upper gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 270 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 270 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 270 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 270 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 270 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 270 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 270 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 270 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 270 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 270 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 270 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 270 at risk

Adverse event: Normocytic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 270 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 270 at risk

Adverse event: Asthenia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 270 at risk

Adverse event: Thirst
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 270 at risk

Adverse event: Cervical spinal stenosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 270 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 270 at risk

Adverse event: Neuropathic arthropathy
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 270 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 270 at risk

Adverse event: Pathological fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 270 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 270 at risk

Adverse event: Lip and/or oral cavity cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 270 at risk

Adverse event: Oropharyngeal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 270 at risk

Adverse event: Smooth muscle cell neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 270 at risk

Adverse event: Erythema
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 270 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 270 at risk

Adverse event: Calculus urethral
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 270 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 270 at risk

Adverse event: Congenital cystic kidney disease
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 270 at risk

Adverse event: Vertigo positional
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 270 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 270 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 270 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 270 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 270 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 22 affected / 270 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 270 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 270 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 270 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 136 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 136 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 136 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 136 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 136 at risk

Adverse event: Device related bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 136 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 136 at risk

Adverse event: Infected skin ulcer
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 136 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 136 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 136 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 136 at risk

Adverse event: Respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 136 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 136 at risk

Adverse event: Arteriovenous fistula thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 136 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 136 at risk

Adverse event: Arteriovenous fistula site complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 136 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 136 at risk

Adverse event: Vascular graft occlusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 136 at risk

Adverse event: Arteriovenous fistula occlusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 136 at risk

Adverse event: Arteriovenous graft site stenosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 136 at risk

Adverse event: Joint injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 136 at risk

Adverse event: Post procedural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 136 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 136 at risk

Adverse event: Vascular access complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 136 at risk

Adverse event: Vascular access malfunction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 136 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 136 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 136 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 136 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 136 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 136 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 136 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 136 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 136 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 136 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 136 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 136 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 136 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 136 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 136 at risk

Adverse event: Atrioventricular block complete
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 136 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 136 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 136 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 136 at risk

Adverse event: Diabetic hyperglycaemic coma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 136 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 136 at risk

Adverse event: Lumbar radiculopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 136 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 136 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 136 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Impaired gastric emptying
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 136 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 136 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Epistaxis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 136 at risk

Adverse event: Hypervolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 136 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 136 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 136 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 136 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 136 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 136 at risk

Adverse event: Catheter site inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 136 at risk

Adverse event: Device related thrombosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 136 at risk

Adverse event: General physical health deterioration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 136 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 136 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 136 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 / 136 at risk

Adverse event: Diabetic foot
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 136 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 136 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 136 at risk

Adverse event: Hyperparathyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 136 at risk

Adverse event: Thrombosis in device
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 136 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 136 at risk

Adverse event: Postmenopausal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 136 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 136 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 136 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 136 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 136 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 14 affected / 136 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 136 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 136 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 136 at risk