Study: NCT00448708

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 1 affected / 110 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 3 affected / 110 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 1 affected / 110 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 1 affected / 110 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 1 affected / 110 at risk

Adverse event: Cachexia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 1 affected / 110 at risk

Adverse event: Pancreatic carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 1 affected / 110 at risk

Adverse event: Dementia Alzhemier's type
Serious: yes
Organ System: Nervous system disorders
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 1 affected / 110 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 1 affected / 110 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 3 affected / 110 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 1 affected / 110 at risk

Adverse event: Death unknown cause
Serious: yes
Organ System: General disorders
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 2 affected / 110 at risk

Adverse event: Graft infection
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 110 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 15 affected / 110 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 12 affected / 110 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 110 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 110 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 110 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 110 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 110 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 110 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 110 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 110 at risk

Adverse event: Complication associated with device
Serious: no
Organ System: General disorders
Frequency: 4 affected / 110 at risk

Adverse event: Catheter site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 2 affected / 110 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 14 affected / 110 at risk

Adverse event: Generalized oedema
Serious: no
Organ System: General disorders
Frequency: 8 affected / 110 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 26 affected / 110 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 17 affected / 110 at risk

Adverse event: Bacteraemia
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 110 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 110 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 110 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 110 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 110 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 110 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 110 at risk

Adverse event: Graft haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 110 at risk

Adverse event: Graft thrombosis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 41 affected / 110 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 110 at risk

Adverse event: Breath sounds abnormal
Serious: no
Organ System: Investigations
Frequency: 12 affected / 110 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 110 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 110 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 110 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 110 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 110 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 110 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 26 affected / 110 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 110 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 110 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 110 at risk

Adverse event: Unresponsive to stimuli
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 110 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 6 affected / 110 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 110 at risk

Adverse event: Mental status changes
Serious: no
Organ System: Psychiatric disorders
Frequency: 7 affected / 110 at risk

Adverse event: Anuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 110 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 110 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 110 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 110 at risk

Adverse event: Rales
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 110 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 110 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 110 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 110 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 110 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 110 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 110 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 19 affected / 110 at risk

Adverse event: Steal syndrome
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 110 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 110 at risk

Adverse event: Venous stenosis
Serious: no
Organ System: Vascular disorders
Frequency: 11 affected / 110 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 2 affected / 112 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 1 affected / 112 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 1 affected / 112 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 1 affected / 112 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 1 affected / 112 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 1 affected / 112 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 2 affected / 112 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 1 affected / 112 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 1 affected / 112 at risk

Adverse event: Haemorrhage stroke
Serious: yes
Organ System: Nervous system disorders
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 1 affected / 112 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 1 affected / 112 at risk

Adverse event: Chronic kidney disease
Serious: yes
Organ System: Renal and urinary disorders
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 1 affected / 112 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 1 affected / 112 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 1 affected / 112 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 1 affected / 112 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 1 affected / 112 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 2 affected / 112 at risk

Adverse event: Death unknown cause
Serious: yes
Organ System: General disorders
Notes: This adverse event resulted in death. Note: In this study, adverse events were never specifically captured as Serious Adverse Events. For this reason, no data other than "adverse events that resulted in death" are available for this category.
Frequency: 1 affected / 112 at risk

Adverse event: Graft infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 112 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 112 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 112 at risk

Adverse event: Cardiac failure congestive
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 112 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 112 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 112 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 112 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 112 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 112 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 112 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 112 at risk

Adverse event: Complication associated with device
Serious: no
Organ System: General disorders
Frequency: 6 affected / 112 at risk

Adverse event: Catheter site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 7 affected / 112 at risk

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 10 affected / 112 at risk

Adverse event: Generalized oedema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 112 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 21 affected / 112 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 112 at risk

Adverse event: Device related infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 112 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 112 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 112 at risk

Adverse event: Sepsis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 112 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 112 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 112 at risk

Adverse event: Graft haemorrhage
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 112 at risk

Adverse event: Graft thrombosis
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 51 affected / 112 at risk

Adverse event: Breath sounds abnormal
Serious: no
Organ System: Investigations
Frequency: 12 affected / 112 at risk

Adverse event: Dehydration
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 112 at risk

Adverse event: Hypervolaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 112 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 112 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 112 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 112 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 112 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 24 affected / 112 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 112 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 112 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 112 at risk

Adverse event: Unresponsive to stimuli
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 112 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 112 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 9 affected / 112 at risk

Adverse event: Mental status changes
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 112 at risk

Adverse event: Anuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 112 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 112 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 112 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 112 at risk

Adverse event: Rales
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 112 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 112 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 112 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 112 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 112 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 112 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 15 affected / 112 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 23 affected / 112 at risk

Adverse event: Steal syndrome
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 112 at risk

Adverse event: Thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 112 at risk

Adverse event: Venous stenosis
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 112 at risk