Study: NCT00844532

Adverse event: Haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Access Site Complication
Frequency: 1 affected / 151 at risk

Adverse event: Pain at insertion site
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Access Site Complication
Frequency: 1 affected / 151 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Access Site Complication
Frequency: 1 affected / 151 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Blood Dyscrasia
Frequency: 8 affected / 151 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Blood Dyscrasia
Frequency: 1 affected / 151 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 9 affected / 151 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 151 at risk

Adverse event: Arrhythmias (other than bradycardia)
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 151 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 151 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 151 at risk

Adverse event: Other: Chest Pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Other: Coronary Artery Disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 151 at risk

Adverse event: Pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 151 at risk

Adverse event: Surgery/Interventional Procedure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 151 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac/Hemodynamic
Frequency: 1 affected / 151 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac/Hemodynamic
Frequency: 1 affected / 151 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac/Hemodynamic
Frequency: 4 affected / 151 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Notes: Cardiac/Hemodynamic
Frequency: 1 affected / 151 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 151 at risk

Adverse event: Gastro-intestinal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 151 at risk

Adverse event: Other: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 151 at risk

Adverse event: Other: Esophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Other: Hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Other: Malnutrition
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Other: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 151 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: Gastro-intestinal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: Other: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 151 at risk

Adverse event: Other: Facial Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: Other: Foot Ulcer
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: Other: Inguinal Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: Other: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: Other: Pancreatitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 151 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 151 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 151 at risk

Adverse event: Viral, bacterial and fungal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 151 at risk

Adverse event: Wound complication or wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 151 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 151 at risk

Adverse event: Other: Hyperglycemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 151 at risk

Adverse event: Other: Hypoglycemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 151 at risk

Adverse event: Genito-urinary
Serious: yes
Organ System: General disorders
Notes: Miscellaneous
Frequency: 2 affected / 151 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Notes: Miscellaneous
Frequency: 1 affected / 151 at risk

Adverse event: Musculoskeletal
Serious: yes
Organ System: General disorders
Notes: Miscellaneous
Frequency: 9 affected / 151 at risk

Adverse event: Other: Non Cardiac Chest Pain
Serious: yes
Organ System: General disorders
Notes: Miscellaneous
Frequency: 1 affected / 151 at risk

Adverse event: Surgery/Interventional Procedure
Serious: yes
Organ System: General disorders
Notes: Miscellaneous
Frequency: 2 affected / 151 at risk

Adverse event: Wound complication or wound infection
Serious: yes
Organ System: General disorders
Notes: Miscellaneous
Frequency: 1 affected / 151 at risk

Adverse event: Myocardial Infarction - Non-Q- wave
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Myocardial Infarction - Unknown
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 151 at risk

Adverse event: Other: Non Stemi MI
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 151 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Notes: Neurologic other than stroke
Frequency: 1 affected / 151 at risk

Adverse event: Mental Status Change
Serious: yes
Organ System: Nervous system disorders
Notes: Neurologic other than stroke
Frequency: 2 affected / 151 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Nervous system disorders
Notes: Neurologic other than stroke
Frequency: 1 affected / 151 at risk

Adverse event: Other: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Notes: Neurologic other than stroke
Frequency: 1 affected / 151 at risk

Adverse event: Other: Anoxic Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Notes: Neurologic other than stroke
Frequency: 1 affected / 151 at risk

Adverse event: Other: Anxiety
Serious: yes
Organ System: Nervous system disorders
Notes: Neurologic other than stroke
Frequency: 1 affected / 151 at risk

Adverse event: Other: Extremity Tremors
Serious: yes
Organ System: Nervous system disorders
Notes: Neurologic other than stroke
Frequency: 1 affected / 151 at risk

Adverse event: Other: Metabolic Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Notes: Neurologic other than stroke
Frequency: 1 affected / 151 at risk

Adverse event: Other: Subarachnoid/Intracerebral Hemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: Neurologic other than stroke
Frequency: 1 affected / 151 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: Neurologic other than stroke
Frequency: 1 affected / 151 at risk

Adverse event: Surgery/Interventional Procedure
Serious: yes
Organ System: Nervous system disorders
Notes: Neurologic other than stroke
Frequency: 1 affected / 151 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Notes: Neurologic other than stroke
Frequency: 2 affected / 151 at risk

Adverse event: Dissection
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Procedure-related
Frequency: 4 affected / 151 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Procedure-related
Frequency: 1 affected / 151 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pulmonary
Frequency: 4 affected / 151 at risk

Adverse event: Other: Pleural Effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pulmonary
Frequency: 2 affected / 151 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 151 at risk

Adverse event: Other: Drug Toxicity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 151 at risk

Adverse event: Other: Dyspnea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 151 at risk

Adverse event: Other: Shortness Of Breath
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 1 affected / 151 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 2 affected / 151 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Respiratory
Frequency: 7 affected / 151 at risk

Adverse event: Other: cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Notes: Stroke
Frequency: 2 affected / 151 at risk

Adverse event: Other: Right Cerebellar Infarct
Serious: yes
Organ System: Vascular disorders
Notes: Stroke
Frequency: 1 affected / 151 at risk

Adverse event: Stroke: Unknown
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 151 at risk

Adverse event: Aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 151 at risk

Adverse event: Dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 151 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 151 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 151 at risk

Adverse event: Vascular occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 9 affected / 151 at risk

Adverse event: Other: Carotid Stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 151 at risk

Adverse event: Other: Deep Vein Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 151 at risk

Adverse event: Other: Peripheral Vascular Disease
Serious: yes
Organ System: Vascular disorders
Frequency: 14 affected / 151 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 151 at risk

Adverse event: Restenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 151 at risk

Adverse event: Stenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 21 affected / 151 at risk

Adverse event: Surgery/Interventional Procedure
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 151 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 151 at risk

Adverse event: Arrhythmias (other than bradycardia)
Serious: no
Organ System: Cardiac disorders
Notes: Cardiac
Frequency: 8 affected / 151 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Cardiac/Hemodynamic
Frequency: 10 affected / 151 at risk

Adverse event: Edema (non pulmonary)
Serious: no
Organ System: General disorders
Frequency: 8 affected / 151 at risk

Adverse event: Musculoskeletal
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 53 affected / 151 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 151 at risk

Adverse event: Other: Peripheral Vascular Disease
Serious: no
Organ System: Vascular disorders
Frequency: 21 affected / 151 at risk

Adverse event: Stenosis
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 151 at risk