Study: NCT00114972

Adverse event: Abnormal blood test values
Serious: yes
Organ System: Investigations
Notes: Total of all abnormal blood tests (increased or decreased) and abnormal diagnostic procedures. Occurrence of each individual event term is less than 1%.
Frequency: 14 affected / 897 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 897 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 27 affected / 897 at risk

Adverse event: Anaphylactic shock , reaction and drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: Total of events related to immune system disorder like anaphylactic reaction or shock and drug hypersensitivity. Occurrence of each individual event term is less than 1%.
Frequency: 1 affected / 897 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 30 affected / 897 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 30 affected / 897 at risk

Adverse event: Arrhythmia, other rare cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Notes: Rare cardiac disorders like ventricular arrhytmias, atrioventricular blocks, cardiomyopathy, valve disease, coronary artery dissection and occlusion. Occurrence of each individual event term is less than 1%.
Frequency: 51 affected / 897 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 45 affected / 897 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 897 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 897 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 897 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 897 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 897 at risk

Adverse event: Myocardial necrosis marker increased
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 897 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 897 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 897 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 9 affected / 897 at risk

Adverse event: Cataract, lens disorder, renal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 897 at risk

Adverse event: Catheter site haematoma
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 897 at risk

Adverse event: Coronary artery thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 897 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 897 at risk

Adverse event: Hepatobiliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Total of hepatobiliary disorders like bile duct stone, cholecystitis, hepatic failure and hepatic function abnormal.Occurrence of each individual event term is less than 1%.
Frequency: 7 affected / 897 at risk

Adverse event: Infection and abcess
Serious: yes
Organ System: Infections and infestations
Notes: Total of any other infection or abcess. Occurrence of each individual event term is less than 1%.
Frequency: 44 affected / 897 at risk

Adverse event: Injury and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Total of all other procedural complications and injuries. Occurrence of each individual event term is less than 1%.
Frequency: 33 affected / 897 at risk

Adverse event: Metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Total of all metabolism and nutrition disorders like hyper- and hypoglycaemie, hypokalaemia, hyponatraemia, dehydration, etc. Occurrence of each individual event term is less than 1%.
Frequency: 12 affected / 897 at risk

Adverse event: Musculoskeletal and connective tissue diorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Total of musculoskeletal and connective tissue disorders. Occurrence of each individual event term is less than 1%.
Frequency: 12 affected / 897 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 897 at risk

Adverse event: Neoplasms
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Total of neoplasms, benign, malignant and unspecified. Occurrence of each individual event term is less than 1%.
Frequency: 11 affected / 897 at risk

Adverse event: Nervous system disorder
Serious: yes
Organ System: Nervous system disorders
Notes: Total of all other nervous system disorders. Occurrence of each individual event term is less than 1%.
Frequency: 23 affected / 897 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 897 at risk

Adverse event: Other gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Sum of all other gastrointestinal disorders like ulcers, pain, hernia, obstructions, vomiting, nausea, etc. Occurrence of each individual event term is less than 1%.
Frequency: 21 affected / 897 at risk

Adverse event: Other general disorders and administration site conditions
Serious: yes
Organ System: General disorders
Notes: Other general disorders mainly related to catheter site events like pain, haemorrhage and pyrexia, multi-organ failure, wound healing problems. Occurrence of each individual event term is less than 1%.
Frequency: 27 affected / 897 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 897 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 26 affected / 897 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 897 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 897 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 897 at risk

Adverse event: Prostatic disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Total of all reproductive system and breast disorders. All events in this system were related to prostatic disorders. Occurrence of each individual event term is less than 1%.
Frequency: 6 affected / 897 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Notes: Total of all psychiatric disorders. Occurrence of each individual event term is less than 1%.
Frequency: 12 affected / 897 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 897 at risk

Adverse event: Renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Notes: Total of all other renal and urinary disorders. Occurrence of each individual event term is less than 1%.
Frequency: 13 affected / 897 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 22 affected / 897 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Total of all other respiratory, thoracic and mediastinal disorders. Occurrence of each individual event term is less than 1%.
Frequency: 31 affected / 897 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 897 at risk

Adverse event: Surgical and medical procedures
Serious: yes
Organ System: Surgical and medical procedures
Notes: Total of surgical and medical procedures. Occurrence of each individual event term is less than 1%.
Frequency: 2 affected / 897 at risk

Adverse event: Vascular disorders
Serious: yes
Organ System: Vascular disorders
Notes: Total of vascular disorders. Occurrence of each individual event term is less than 1%.
Frequency: 45 affected / 897 at risk

Adverse event: Vascular graft occlusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 28 affected / 897 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 30 affected / 897 at risk

Adverse event: coagulopathy, iron deficiency anaemia, leukocytosis, thrombocyopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Total of other events and subjects affected with these events in this organ system. Event terms are coagulopathy, iron deficiency anaemia, leukocytosis and thrombocyopenia. Occurrence of each individual event term is less than 1%.
Frequency: 4 affected / 897 at risk

Adverse event: skin and subcutaneous tissue disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Total of skin and subcutaneous tissue disorders. Occurrence of each individual event term is less than 1%.
Frequency: 4 affected / 897 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 104 affected / 897 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 26 affected / 897 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 123 affected / 897 at risk

Adverse event: Incision site complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 47 affected / 897 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 54 affected / 897 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 56 affected / 897 at risk

Adverse event: All other Adverse Events
Serious: no
Organ System: General disorders
Notes: Total of all other adverse events with an occurrence below the 5% treshold.
Frequency: 509 affected / 897 at risk

Adverse event: Abnormal blood test values
Serious: yes
Organ System: Investigations
Notes: Total of all abnormal blood tests (increased or decreased) and abnormal diagnostic procedures. Occurrence of each individual event term is less than 1%.
Frequency: 18 affected / 903 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 903 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 903 at risk

Adverse event: Anaphylactic shock , reaction and drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Notes: Total of events related to immune system disorder like anaphylactic reaction or shock and drug hypersensitivity. Occurrence of each individual event term is less than 1%.
Frequency: 2 affected / 903 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 74 affected / 903 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 66 affected / 903 at risk

Adverse event: Arrhythmia, other rare cardiac disorders
Serious: yes
Organ System: Cardiac disorders
Notes: Rare cardiac disorders like ventricular arrhytmias, atrioventricular blocks, cardiomyopathy, valve disease, coronary artery dissection and occlusion. Occurrence of each individual event term is less than 1%.
Frequency: 82 affected / 903 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 903 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 903 at risk

Adverse event: Graves' disease
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 903 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 13 affected / 903 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 15 affected / 903 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 903 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 903 at risk

Adverse event: Myocardial necrosis marker increased
Serious: yes
Organ System: Investigations
Frequency: 10 affected / 903 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 903 at risk

Adverse event: Cardiogenic shock
Serious: yes
Organ System: Cardiac disorders
Frequency: 14 affected / 903 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 903 at risk

Adverse event: Cataract, lens disorder, renal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 3 affected / 903 at risk

Adverse event: Catheter site haematoma
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 903 at risk

Adverse event: Coronary artery thrombosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 28 affected / 903 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 903 at risk

Adverse event: Hepatobiliary disorders
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Total of hepatobiliary disorders like bile duct stone, cholecystitis, hepatic failure and hepatic function abnormal.Occurrence of each individual event term is less than 1%.
Frequency: 3 affected / 903 at risk

Adverse event: Infection and abcess
Serious: yes
Organ System: Infections and infestations
Notes: Total of any other infection or abcess. Occurrence of each individual event term is less than 1%.
Frequency: 27 affected / 903 at risk

Adverse event: Injury and procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Total of all other procedural complications and injuries. Occurrence of each individual event term is less than 1%.
Frequency: 15 affected / 903 at risk

Adverse event: Metabolism and nutrition disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Total of all metabolism and nutrition disorders like hyper- and hypoglycaemie, hypokalaemia, hyponatraemia, dehydration, etc. Occurrence of each individual event term is less than 1%.
Frequency: 6 affected / 903 at risk

Adverse event: Musculoskeletal and connective tissue diorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Total of musculoskeletal and connective tissue disorders. Occurrence of each individual event term is less than 1%.
Frequency: 12 affected / 903 at risk

Adverse event: Myocardial ischaemia
Serious: yes
Organ System: Cardiac disorders
Frequency: 18 affected / 903 at risk

Adverse event: Neoplasms
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Total of neoplasms, benign, malignant and unspecified. Occurrence of each individual event term is less than 1%.
Frequency: 14 affected / 903 at risk

Adverse event: Nervous system disorder
Serious: yes
Organ System: Nervous system disorders
Notes: Total of all other nervous system disorders. Occurrence of each individual event term is less than 1%.
Frequency: 13 affected / 903 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 14 affected / 903 at risk

Adverse event: Other gastrointestinal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Sum of all other gastrointestinal disorders like ulcers, pain, hernia, obstructions, vomiting, nausea, etc. Occurrence of each individual event term is less than 1%.
Frequency: 11 affected / 903 at risk

Adverse event: Other general disorders and administration site conditions
Serious: yes
Organ System: General disorders
Notes: Other general disorders mainly related to catheter site events like pain, haemorrhage and pyrexia, multi-organ failure, wound healing problems. Occurrence of each individual event term is less than 1%.
Frequency: 26 affected / 903 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 903 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 903 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 903 at risk

Adverse event: Prostatic disorders
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Total of all reproductive system and breast disorders. All events in this system were related to prostatic disorders. Occurrence of each individual event term is less than 1%.
Frequency: 1 affected / 903 at risk

Adverse event: Psychiatric disorders
Serious: yes
Organ System: Psychiatric disorders
Notes: Total of all psychiatric disorders. Occurrence of each individual event term is less than 1%.
Frequency: 3 affected / 903 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 903 at risk

Adverse event: Renal and urinary disorders
Serious: yes
Organ System: Renal and urinary disorders
Notes: Total of all other renal and urinary disorders. Occurrence of each individual event term is less than 1%.
Frequency: 13 affected / 903 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 903 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Total of all other respiratory, thoracic and mediastinal disorders. Occurrence of each individual event term is less than 1%.
Frequency: 20 affected / 903 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 903 at risk

Adverse event: Vascular disorders
Serious: yes
Organ System: Vascular disorders
Notes: Total of vascular disorders. Occurrence of each individual event term is less than 1%.
Frequency: 48 affected / 903 at risk

Adverse event: Vascular graft occlusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 903 at risk

Adverse event: Vertigo positional
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 903 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 903 at risk

Adverse event: coagulopathy, iron deficiency anaemia, leukocytosis, thrombocyopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Total of other events and subjects affected with these events in this organ system. Event terms are coagulopathy, iron deficiency anaemia, leukocytosis and thrombocyopenia. Occurrence of each individual event term is less than 1%.
Frequency: 3 affected / 903 at risk

Adverse event: skin and subcutaneous tissue disorders
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Total of skin and subcutaneous tissue disorders. Occurrence of each individual event term is less than 1%.
Frequency: 3 affected / 903 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 23 affected / 903 at risk

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 61 affected / 903 at risk

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 25 affected / 903 at risk

Adverse event: Incision site complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 903 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 903 at risk

Adverse event: Wound infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 903 at risk

Adverse event: All other Adverse Events
Serious: no
Organ System: General disorders
Notes: Total of all other adverse events with an occurrence below the 5% treshold.
Frequency: 405 affected / 903 at risk