Study: NCT03724812

Adverse event: Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 46 at risk

Adverse event: Endocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk

Adverse event: Atrioventricular block
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 46 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 46 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 46 at risk

Adverse event: Bacterial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 46 at risk

Adverse event: General
Serious: yes
Organ System: General disorders
Frequency: 10 affected / 46 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 46 at risk

Adverse event: Vascular Access Site Complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 46 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 46 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 46 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 46 at risk

Adverse event: General-Musculoskeletal Symptoms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Seizure/Convulsions/Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 46 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 46 at risk

Adverse event: Arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 46 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 46 at risk

Adverse event: Atrioventricular block
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 46 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 46 at risk

Adverse event: Anemias
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 46 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: General
Frequency: 1 affected / 46 at risk

Adverse event: Haematoma
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: General
Frequency: 2 affected / 46 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 46 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 7 affected / 46 at risk

Adverse event: Dental Disorders
Serious: no
Organ System: General disorders
Frequency: 1 affected / 46 at risk

Adverse event: Thyroid Disorders
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 46 at risk

Adverse event: Oedema
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 46 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 46 at risk

Adverse event: Aortic Valve Regurgitation/Aortic Valve Insufficiency/Valvular Regurgitation Aortic Valve
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 46 at risk