Study: NCT02649426

Adverse event: Atrioventricular block - Drug therapy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 74 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 74 at risk

Adverse event: Bradycardia - Drug therapy
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 74 at risk

Adverse event: Presyncope - Drug therapy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 74 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 74 at risk

Adverse event: Renal artery stenosis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Independent review of preprocedural and 6-month post procedure renal artery imaging showed that there was a pre-existing ostial renal artery stenosis which would have met the criteria for exclusion but was not recognized at the time of randomization.
Frequency: 1 affected / 74 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 74 at risk

Adverse event: Vascular access site haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 11 affected / 74 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 74 at risk

Adverse event: Vascular access site pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 13 affected / 74 at risk

Adverse event: Vasospasm
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 74 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 5 affected / 74 at risk

Adverse event: Hypertension - Condition aggravated
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 74 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 74 at risk

Adverse event: Vasospasm - Drug therapy
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 74 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 72 at risk

Adverse event: Vascular access site haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 13 affected / 72 at risk

Adverse event: Vascular access site pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 10 affected / 72 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 72 at risk

Adverse event: Hypertension - Condition aggravated
Serious: no
Organ System: Cardiac disorders
Frequency: 9 affected / 72 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 69 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 69 at risk

Adverse event: Sedation complication - Drug therapy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 69 at risk

Adverse event: Vascular access site haematoma
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 69 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 69 at risk

Adverse event: Adverse drug reaction - Sevikar HCT (Amlodipine, Olmesartan and Hydrochlorothiazide)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 69 at risk

Adverse event: Blood sodium abnormal
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 69 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 69 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 69 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 69 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 69 at risk

Adverse event: Vascular access site haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 10 affected / 69 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 69 at risk

Adverse event: Vascular access site pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 9 affected / 69 at risk

Adverse event: Vasospasm
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 69 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 69 at risk

Adverse event: Hypertension - Condition aggravated
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 69 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 69 at risk

Adverse event: Vasospasm - Drug therapy
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 69 at risk

Adverse event: Haematoma infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 67 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 67 at risk

Adverse event: Cholecystectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 67 at risk

Adverse event: Coronary arterial stent insertion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 67 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 67 at risk

Adverse event: Vascular access site haematoma
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 67 at risk

Adverse event: Vascular access site pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 9 affected / 67 at risk

Adverse event: Vasospasm
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 67 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 5 affected / 67 at risk

Adverse event: Hypertension - Condition aggravated
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 67 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 67 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 59 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 59 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 59 at risk

Adverse event: Vascular access site pain
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 59 at risk

Adverse event: Vasospasm
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 59 at risk