Study: NCT01445613

Adverse event: Haematoma
Serious: yes
Organ System: General disorders
Notes: Access Site Complication
Frequency: 1 affected / 1200 at risk

Adverse event: Infection At Insertion Site
Serious: yes
Organ System: General disorders
Notes: Access Site Complication
Frequency: 1 affected / 1200 at risk

Adverse event: Other: under access site complication
Serious: yes
Organ System: General disorders
Notes: Access Site Complication
Frequency: 1 affected / 1200 at risk

Adverse event: Allergic Reaction To Contrast
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Blood Dyscrasia
Frequency: 7 affected / 1200 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Blood Dyscrasia
Frequency: 1 affected / 1200 at risk

Adverse event: Coagulopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Blood Dyscrasia
Frequency: 1 affected / 1200 at risk

Adverse event: Malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 1200 at risk

Adverse event: Abnormal Lab Test
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1200 at risk

Adverse event: Arrhythmia (Includes Brady And Tachy)
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 1200 at risk

Adverse event: Coronary artery disease - Coronary stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 1200 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1200 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 1200 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 1200 at risk

Adverse event: Myocardial Infarction - Non Q wave
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Myocardial Infarction - Q wave
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Myocardial Infarction - Unknown
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1200 at risk

Adverse event: Surgery/Intervention Procedure
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1200 at risk

Adverse event: Syncope
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Other
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Other
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1200 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Kidney Damage Due To Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Malignant
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Renal Artery Disease
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Surgery/Intervention Procedure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Neoplasm
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Urinary Retension
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Other
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1200 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1200 at risk

Adverse event: Wound Complication Or Wound Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1200 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Sensory loss
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Surgery/Intervention Procedure
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Abnormal Lab Test
Serious: yes
Organ System: General disorders
Notes: Miscellaneous
Frequency: 1 affected / 1200 at risk

Adverse event: Anxiety
Serious: yes
Organ System: General disorders
Notes: Miscellaneous
Frequency: 1 affected / 1200 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: General disorders
Notes: Miscellaneous
Frequency: 1 affected / 1200 at risk

Adverse event: Depression
Serious: yes
Organ System: General disorders
Notes: Miscellaneous
Frequency: 1 affected / 1200 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: General disorders
Notes: Miscellaneous
Frequency: 1 affected / 1200 at risk

Adverse event: Other: under miscellaneous category
Serious: yes
Organ System: General disorders
Notes: Miscellaneous
Frequency: 7 affected / 1200 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Other
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 1200 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 1200 at risk

Adverse event: Delerium
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Mental Status Change
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Post Traumatic Hemorrage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Speech Disturbance
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 1200 at risk

Adverse event: Transient Ischemia Attack
Serious: yes
Organ System: Nervous system disorders
Frequency: 12 affected / 1200 at risk

Adverse event: Vasovagal
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Visual impairment
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Other
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Anaemia
Serious: yes
Organ System: General disorders
Notes: Procedure Related
Frequency: 5 affected / 1200 at risk

Adverse event: Arrhythmia (Includes Brady And Tachy)
Serious: yes
Organ System: General disorders
Notes: Procedure Related
Frequency: 18 affected / 1200 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: General disorders
Notes: Procedure Related
Frequency: 2 affected / 1200 at risk

Adverse event: Colitis
Serious: yes
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Dissection
Serious: yes
Organ System: General disorders
Notes: Procedure Related
Frequency: 3 affected / 1200 at risk

Adverse event: Embolism
Serious: yes
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Headache
Serious: yes
Organ System: General disorders
Notes: Procedure Related
Frequency: 2 affected / 1200 at risk

Adverse event: Hemiparesis
Serious: yes
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Hypertension
Serious: yes
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Hypotension
Serious: yes
Organ System: General disorders
Notes: Procedure Related
Frequency: 60 affected / 1200 at risk

Adverse event: Incisional Pain
Serious: yes
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Infection At Insertion Site
Serious: yes
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Ischaemia
Serious: yes
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: No reflow
Serious: yes
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Notes: Procedure Related
Frequency: 2 affected / 1200 at risk

Adverse event: Pain At Insertion Site
Serious: yes
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: General disorders
Notes: Procedure Related
Frequency: 6 affected / 1200 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Transient Ischemia Attack
Serious: yes
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Vessel Trauma
Serious: yes
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Viral, Bacterial And Fungal Infections
Serious: yes
Organ System: General disorders
Notes: Procedure Related
Frequency: 2 affected / 1200 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 1200 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 1200 at risk

Adverse event: Other
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Cerebrovascular accident - Major Hemorrhagic Ispilateral
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Cerebrovascular accident - Major Hemorrhagic Non-Ispilateral
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Cerebrovascular accident - Major Ischemic Ispilateral
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 1200 at risk

Adverse event: Cerebrovascular accident - Major Ischemic Non-Ispilateral
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Cerebrovascular accident - Minor Hemorrhagic Bilateral
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Cerebrovascular accident - Minor Hemorrhagic Ispilateral
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Cerebrovascular accident - Minor Hemorrhagic Non-Ispilateral
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Cerebrovascular accident - Minor Ischemic Bilateral
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Cerebrovascular accident - Minor Ischemic Ispilateral
Serious: yes
Organ System: Vascular disorders
Frequency: 23 affected / 1200 at risk

Adverse event: Cerebrovascular accident - Minor Ischemic Non-Ispilateral
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Intermittent claudication
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 1200 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Vascular occlusion
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Peripheral artery disease
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Peripheral vascular disorder
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Restenosis
Serious: yes
Organ System: Vascular disorders
Frequency: 10 affected / 1200 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Vascular
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Other
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 1200 at risk

Adverse event: Arrhythmia (Includes Brady And Tachy)
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 107 affected / 1200 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 242 affected / 1200 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: General disorders
Notes: Access Site Complication
Frequency: 4 affected / 1200 at risk

Adverse event: Ecchymosis/Bruising
Serious: no
Organ System: General disorders
Notes: Access Site Complication
Frequency: 2 affected / 1200 at risk

Adverse event: Haematoma
Serious: no
Organ System: General disorders
Notes: Access Site Complication
Frequency: 6 affected / 1200 at risk

Adverse event: Infection At Insertion Site
Serious: no
Organ System: General disorders
Notes: Access Site Complication
Frequency: 1 affected / 1200 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Access Site Complication
Frequency: 2 affected / 1200 at risk

Adverse event: Pain At Insertion Site
Serious: no
Organ System: General disorders
Notes: Access Site Complication
Frequency: 3 affected / 1200 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Notes: Access Site Complication
Frequency: 2 affected / 1200 at risk

Adverse event: Allergic Reaction To Contrast
Serious: no
Organ System: Immune system disorders
Notes: Allergic Reaction
Frequency: 4 affected / 1200 at risk

Adverse event: Rash
Serious: no
Organ System: Immune system disorders
Notes: Allergic Reaction
Frequency: 6 affected / 1200 at risk

Adverse event: Other
Serious: no
Organ System: Immune system disorders
Notes: Allergic Reaction
Frequency: 5 affected / 1200 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Ecchymosis/Bruising
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Haematoma
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 1200 at risk

Adverse event: Abnormal Lab Test
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Blood Dyscrasia
Frequency: 1 affected / 1200 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Blood Dyscrasia
Frequency: 13 affected / 1200 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Blood Dyscrasia
Frequency: 2 affected / 1200 at risk

Adverse event: Coagulopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Blood Dyscrasia
Frequency: 1 affected / 1200 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Blood Dyscrasia
Frequency: 1 affected / 1200 at risk

Adverse event: Malignant
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 1200 at risk

Adverse event: Abnormal Lab Test
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 1200 at risk

Adverse event: Arrhythmia (Includes Brady And Tachy)
Serious: no
Organ System: Cardiac disorders
Frequency: 42 affected / 1200 at risk

Adverse event: Cardiac arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1200 at risk

Adverse event: CAD - Coronary stenosis
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 1200 at risk

Adverse event: Cardiac arrest
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 1200 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 1200 at risk

Adverse event: Dizziness
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 1200 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Frequency: 23 affected / 1200 at risk

Adverse event: Ischaemia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Myocardial Infarction - Non Q wave
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Myocardial Infarction - Q wave
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Myocardial Infarction - Unknown
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Peripheral vascular disease (PVD)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Pain
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 1200 at risk

Adverse event: Spasm
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Surgery/Intervention Procedure
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 1200 at risk

Adverse event: Syncope
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Vasovagal
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Other
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Diverticulitis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Gastroesophageal reflux disease (GERD)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Gastrointestinal (GI) bleed
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1200 at risk

Adverse event: Abnormal Lab Test
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Incontinence
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Kidney Damage Due To Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Malignant
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Renal Artery Disease
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Renal failure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Sepsis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Surgery/Intervention Procedure
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Neoplasm
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Urinary Retension
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 1200 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 1200 at risk

Adverse event: Viral, Bacterial And Fungal Infections
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Other
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 1200 at risk

Adverse event: Eye
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1200 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1200 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1200 at risk

Adverse event: Viral, Bacterial And Fungal Infections
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 1200 at risk

Adverse event: Wound Complication Or Wound Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1200 at risk

Adverse event: Abnormal Lab Test
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Sensory loss
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Surgery/Intervention Procedure
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Other
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Abnormal Lab Test
Serious: no
Organ System: General disorders
Frequency: 4 affected / 1200 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Intermittent claudication
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Cough
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Depression
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 1200 at risk

Adverse event: Edema (Non Pulmonary)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 13 affected / 1200 at risk

Adverse event: Haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 1200 at risk

Adverse event: Rash
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 18 affected / 1200 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Arthritis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 1200 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Headache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Haematoma
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 1200 at risk

Adverse event: Asthenia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 1200 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Confusional state
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 1200 at risk

Adverse event: Delerium
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 1200 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 1200 at risk

Adverse event: Mental Status Change
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 1200 at risk

Adverse event: Nausea
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Neuralgia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Paralysis
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Post Traumatic Hemorrage
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 1200 at risk

Adverse event: Sensory loss
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Speech Disturbance
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 1200 at risk

Adverse event: Syncope
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 1200 at risk

Adverse event: Transient Ischemia Attack
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 1200 at risk

Adverse event: Vasovagal
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Visual impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 1200 at risk

Adverse event: Asthenia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Other
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 1200 at risk

Adverse event: Abnormal Lab Test
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Access site event
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Allergic Reaction To Contrast
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Anaemia
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 15 affected / 1200 at risk

Adverse event: Anxiety
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Cardiac arrest
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 4 affected / 1200 at risk

Adverse event: Back pain
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 3 affected / 1200 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 10 affected / 1200 at risk

Adverse event: Colitis
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Dissection
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 5 affected / 1200 at risk

Adverse event: Ecchymosis/Bruising
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Embolism
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 2 affected / 1200 at risk

Adverse event: Eye
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 20 affected / 1200 at risk

Adverse event: Haematoma
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 19 affected / 1200 at risk

Adverse event: Hemiparesis
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 23 affected / 1200 at risk

Adverse event: Incisional Pain
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Incontinence
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Infection At Insertion Site
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 2 affected / 1200 at risk

Adverse event: Ischaemia
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Pain in jaw
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Mental Status Change
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 2 affected / 1200 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 18 affected / 1200 at risk

Adverse event: Neuralgia
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: No reflow
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Oozing
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 13 affected / 1200 at risk

Adverse event: Pain At Insertion Site
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 6 affected / 1200 at risk

Adverse event: Paralysis
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Vascular pseudoaneurysm
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 8 affected / 1200 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Renal failure
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Spasm
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 4 affected / 1200 at risk

Adverse event: Speech Disturbance
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Syncope
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Thrombosis
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 2 affected / 1200 at risk

Adverse event: Transient Ischemia Attack
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 3 affected / 1200 at risk

Adverse event: Urinary Retension
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 2 affected / 1200 at risk

Adverse event: Vasospasm
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 4 affected / 1200 at risk

Adverse event: Vasovagal
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 3 affected / 1200 at risk

Adverse event: Vessel Trauma
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 1 affected / 1200 at risk

Adverse event: Viral, Bacterial And Fungal Infections
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 2 affected / 1200 at risk

Adverse event: Visual impairment
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 4 affected / 1200 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 3 affected / 1200 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 2 affected / 1200 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Notes: Procedure Related
Frequency: 11 affected / 1200 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1200 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 1200 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Respiratory failure
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 1200 at risk

Adverse event: Viral, Bacterial And Fungal Infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Other
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Cerebrovascular accident (CVA) - Major Hemorrhagic Ispilateral
Serious: no
Organ System: Vascular disorders
Notes: Stroke
Frequency: 3 affected / 1200 at risk

Adverse event: Cerebrovascular accident (CVA)-Major Hemorrhagic Non-Ispilateral
Serious: no
Organ System: Vascular disorders
Notes: Stroke
Frequency: 1 affected / 1200 at risk

Adverse event: Cerebrovascular accident (CVA) - Major Ischemic Ispilateral
Serious: no
Organ System: Vascular disorders
Notes: Stroke
Frequency: 8 affected / 1200 at risk

Adverse event: Cerebrovascular accident (CVA) - Major Ischemic Non-Ispilateral
Serious: no
Organ System: Vascular disorders
Notes: Stroke
Frequency: 2 affected / 1200 at risk

Adverse event: Cerebrovascular accident (CVA) - Minor Hemorrhagic Bilateral
Serious: no
Organ System: Vascular disorders
Notes: Stroke
Frequency: 1 affected / 1200 at risk

Adverse event: Cerebrovascular accident (CVA) - Minor Hemorrhagic Ispilateral
Serious: no
Organ System: Vascular disorders
Notes: Stroke
Frequency: 2 affected / 1200 at risk

Adverse event: Cerebrovascular accident (CVA) - Minor Hemorrhagic Non-Ispilateral
Serious: no
Organ System: Vascular disorders
Notes: Stroke
Frequency: 1 affected / 1200 at risk

Adverse event: Cerebrovascular accident (CVA) - Minor Ischemic Bilateral
Serious: no
Organ System: Vascular disorders
Notes: Stroke
Frequency: 3 affected / 1200 at risk

Adverse event: Cerebrovascular accident (CVA) - Minor Ischemic Ispilateral
Serious: no
Organ System: Vascular disorders
Notes: Stroke
Frequency: 25 affected / 1200 at risk

Adverse event: Cerebrovascular accident (CVA) - Minor Ischemic Non-Ispilateral
Serious: no
Organ System: Vascular disorders
Notes: Stroke
Frequency: 4 affected / 1200 at risk

Adverse event: Aneurysm
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Arrhythmia (Includes Brady And Tachy)
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Intermittent claudication
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 1200 at risk

Adverse event: Deep venous thrombosis (DVT)
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Dissection
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Vascular occlusion
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 1200 at risk

Adverse event: Peripheral artery disease (PAD)
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 1200 at risk

Adverse event: Peripheral vascular disease (PVD)
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 1200 at risk

Adverse event: Restenosis
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 1200 at risk

Adverse event: Spasm
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Surgery/Intervention Procedure
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Syncope
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 1200 at risk

Adverse event: Vascular
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Vasospasm
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Vasovagal
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 1200 at risk

Adverse event: Other
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 1200 at risk