Study: NCT01537302

Adverse event: AV Fistula
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 100 at risk

Adverse event: Vessel Dissection, Grade C or greater
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 100 at risk

Adverse event: Vessel Dissection, Grade A or B
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 100 at risk

Adverse event: Bruising or hemorrhage at procedural access site
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 100 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 100 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 100 at risk

Adverse event: Pain, new or worsening
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 100 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 100 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 100 at risk

Adverse event: Bleeding (other than access site)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 100 at risk

Adverse event: Hypotension, sustained
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 100 at risk

Adverse event: Perforation requiring intervention
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 100 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 100 at risk

Adverse event: Perforation, not requiring intervention
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 100 at risk

Adverse event: Acute COPD exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Peripheral ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 100 at risk

Adverse event: Aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 100 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 100 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 100 at risk

Adverse event: Allergic reaction to contrast medium
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Altered mental state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 100 at risk

Adverse event: Leg ulcerations
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 100 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 100 at risk

Adverse event: Intractable nausea/vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Lethargy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 100 at risk

Adverse event: Uncontrolled hyperglycemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 100 at risk

Adverse event: Bruising or hemorrhage at procedural access site
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 100 at risk

Adverse event: Swelling
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 100 at risk

Adverse event: Bleeding, other than access site
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 100 at risk

Adverse event: Confusional state
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 100 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: General disorders
Frequency: 4 affected / 100 at risk

Adverse event: Pain, new or worsening
Serious: no
Organ System: General disorders
Frequency: 3 affected / 100 at risk

Adverse event: Perforation not requiring intervention
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 100 at risk

Adverse event: Vascular pseudoaneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 100 at risk

Adverse event: Vessel dissection, Grade A or B
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 100 at risk

Adverse event: Vessel dissection, Grade C or greater
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 100 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: AV fistula
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 100 at risk