Study: NCT00490841

Adverse event: Haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Access site complication
Frequency: 1 affected / 199 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Surgical and medical procedures
Notes: Access Site Complication
Frequency: 1 affected / 199 at risk

Adverse event: Blood disorder
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Anemia
Frequency: 6 affected / 199 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 8 affected / 199 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 199 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac/Hemodynamic
Frequency: 5 affected / 199 at risk

Adverse event: Arrhythmias (Bradycardia & Tachycardia)
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac/Hemodynamic
Frequency: 9 affected / 199 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac/Hemodynamic
Frequency: 1 affected / 199 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac/Hemodynamic
Frequency: 1 affected / 199 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac/Hemodynamic
Frequency: 2 affected / 199 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac/Hemodynamic
Frequency: 7 affected / 199 at risk

Adverse event: Hypertension Exacerbation
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac/Hemodynamic
Frequency: 7 affected / 199 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac/Hemodynamic
Frequency: 2 affected / 199 at risk

Adverse event: Pacemaker Issue
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac/Hemodynamic
Frequency: 1 affected / 199 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac/Hemodynamic
Frequency: 6 affected / 199 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal
Frequency: 1 affected / 199 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal
Frequency: 2 affected / 199 at risk

Adverse event: Digestive Disorder
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal
Frequency: 4 affected / 199 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal
Frequency: 1 affected / 199 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal
Frequency: 2 affected / 199 at risk

Adverse event: Pyloric Channel Ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal
Frequency: 2 affected / 199 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal
Frequency: 2 affected / 199 at risk

Adverse event: Joint/Bone
Serious: yes
Organ System: Infections and infestations
Notes: Infection
Frequency: 2 affected / 199 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Infection
Frequency: 1 affected / 199 at risk

Adverse event: Viral, Bacterial and Fungal Infections
Serious: yes
Organ System: Infections and infestations
Notes: Infection
Frequency: 4 affected / 199 at risk

Adverse event: Electrolyte imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Metabolic
Frequency: 6 affected / 199 at risk

Adverse event: Back pain
Serious: yes
Organ System: General disorders
Notes: Miscellaneous
Frequency: 2 affected / 199 at risk

Adverse event: Edema (Non Pulmonary)
Serious: yes
Organ System: General disorders
Notes: Miscellaneous
Frequency: 1 affected / 199 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: General disorders
Notes: Miscellaneous
Frequency: 3 affected / 199 at risk

Adverse event: Joint/Bone
Serious: yes
Organ System: General disorders
Notes: Miscellaneous
Frequency: 1 affected / 199 at risk

Adverse event: Lightheadedness/Dizziness
Serious: yes
Organ System: General disorders
Notes: Miscellaneous
Frequency: 2 affected / 199 at risk

Adverse event: Medication Side Effect
Serious: yes
Organ System: General disorders
Notes: Miscellaneous
Frequency: 1 affected / 199 at risk

Adverse event: Myalgia
Serious: yes
Organ System: General disorders
Notes: Miscellaneous
Frequency: 1 affected / 199 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Notes: Miscellaneous
Frequency: 1 affected / 199 at risk

Adverse event: Syncope
Serious: yes
Organ System: General disorders
Notes: Miscellaneous
Frequency: 4 affected / 199 at risk

Adverse event: Injury
Serious: yes
Organ System: General disorders
Notes: Miscellaneous
Frequency: 3 affected / 199 at risk

Adverse event: Vision Disturbance
Serious: yes
Organ System: General disorders
Notes: Miscellaneous
Frequency: 1 affected / 199 at risk

Adverse event: Weight Gain/Loss
Serious: yes
Organ System: General disorders
Notes: Miscellaneous
Frequency: 1 affected / 199 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Notes: Neurological
Frequency: 1 affected / 199 at risk

Adverse event: Stroke/Cerebral Vascular Accident
Serious: yes
Organ System: Nervous system disorders
Notes: Neurological
Frequency: 4 affected / 199 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Notes: Neurological
Frequency: 1 affected / 199 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Non-Access Site Bleeding
Frequency: 5 affected / 199 at risk

Adverse event: Retroperitoneal haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Non-Access Site Bleeding
Frequency: 2 affected / 199 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pulmonary/Respiratory
Frequency: 1 affected / 199 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pulmonary/Respiratory
Frequency: 4 affected / 199 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pulmonary/Respiratory
Frequency: 4 affected / 199 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pulmonary/Respiratory
Frequency: 1 affected / 199 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pulmonary/Respiratory
Frequency: 2 affected / 199 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pulmonary/Respiratory
Frequency: 1 affected / 199 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pulmonary/Respiratory
Frequency: 3 affected / 199 at risk

Adverse event: Creatinine Increase
Serious: yes
Organ System: Renal and urinary disorders
Notes: Renal
Frequency: 2 affected / 199 at risk

Adverse event: Cysts/Stones
Serious: yes
Organ System: Renal and urinary disorders
Notes: Renal
Frequency: 1 affected / 199 at risk

Adverse event: Insufficiency
Serious: yes
Organ System: Renal and urinary disorders
Notes: Renal
Frequency: 4 affected / 199 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Renal
Frequency: 2 affected / 199 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Notes: Vascular
Frequency: 2 affected / 199 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Vascular disorders
Notes: Vascular
Frequency: 1 affected / 199 at risk

Adverse event: Restenosis
Serious: yes
Organ System: Vascular disorders
Notes: Vascular
Frequency: 15 affected / 199 at risk

Adverse event: Stenosis
Serious: yes
Organ System: Vascular disorders
Notes: Vascular
Frequency: 16 affected / 199 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Vascular
Frequency: 2 affected / 199 at risk

Adverse event: Total Occlusion
Serious: yes
Organ System: Vascular disorders
Notes: Vascular
Frequency: 2 affected / 199 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Surgical and medical procedures
Notes: Access Site Complication
Frequency: 12 affected / 199 at risk

Adverse event: Haematoma
Serious: no
Organ System: Surgical and medical procedures
Notes: Access Site Complication
Frequency: 19 affected / 199 at risk

Adverse event: Hypertention Exacerbation
Serious: no
Organ System: Cardiac disorders
Notes: Cardiac/Hemodynamic
Frequency: 27 affected / 199 at risk

Adverse event: Digestive Disorder
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal
Frequency: 12 affected / 199 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Gastrointestinal
Frequency: 14 affected / 199 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Infection
Frequency: 12 affected / 199 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Notes: Miscellaneous
Frequency: 22 affected / 199 at risk

Adverse event: Fatigue/Weakness
Serious: no
Organ System: General disorders
Notes: Miscellaneous
Frequency: 11 affected / 199 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Notes: Miscellaneous
Frequency: 11 affected / 199 at risk

Adverse event: Lightheadedness/Dizziness
Serious: no
Organ System: General disorders
Notes: Miscellaneous
Frequency: 15 affected / 199 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Notes: Miscellaneous
Frequency: 11 affected / 199 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Miscellaneous
Frequency: 13 affected / 199 at risk