Study: NCT02312765

Adverse event: Aortic stenosis
Serious: yes
Organ System: Cardiac disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 74 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 74 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 4 affected / 74 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 13 affected / 74 at risk

Adverse event: PVT
Serious: yes
Organ System: Cardiac disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 2 affected / 74 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 74 at risk

Adverse event: Abnormal Liver Enzymes
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 74 at risk

Adverse event: Systemic inflammatory response syndrome
Serious: yes
Organ System: Infections and infestations
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 74 at risk

Adverse event: Gout
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 74 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 74 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 74 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 74 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 74 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 74 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 74 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 74 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 74 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 72 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 72 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 72 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 10 affected / 72 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 72 at risk

Adverse event: Pacemaker bleeding
Serious: yes
Organ System: Cardiac disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 72 at risk

Adverse event: Pacemaker malfunction
Serious: yes
Organ System: Cardiac disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 72 at risk

Adverse event: PVT
Serious: yes
Organ System: Cardiac disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 2 affected / 72 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 72 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 72 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 72 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 72 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 72 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 72 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Renal and urinary disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 72 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 72 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 72 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 72 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Notes: Related? (U=Unrelated, R=Related): U / Expected? Y
Frequency: 1 affected / 72 at risk