Study: NCT00885677

Adverse event: Anaemias nonhaemolytic and marrow depression
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 462 at risk

Adverse event: Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 462 at risk

Adverse event: Cardiac arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 462 at risk

Adverse event: Cardiac disorder signs and symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 16 affected / 462 at risk

Adverse event: Cardiac valve disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 462 at risk

Adverse event: Coronary artery disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 462 at risk

Adverse event: Heart failures
Serious: yes
Organ System: Cardiac disorders
Frequency: 76 affected / 462 at risk

Adverse event: Surgical and medical procedures
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 462 at risk

Adverse event: Vascular disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 462 at risk

Adverse event: Thyroid disorder
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 462 at risk

Adverse event: Anterior eye structural change, deposit and degeneration
Serious: yes
Organ System: Eye disorders
Frequency: 2 affected / 462 at risk

Adverse event: Abdominal hernias and other abdominal wall conditions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 462 at risk

Adverse event: Gastrointestinal haemorrhages NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 462 at risk

Adverse event: Gastrointestinal motility and defaecation conditions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 462 at risk

Adverse event: Gastrointestinal signs and symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 462 at risk

Adverse event: Fatal outcome
Serious: yes
Organ System: General disorders
Frequency: 21 affected / 462 at risk

Adverse event: General system disorders NEC
Serious: yes
Organ System: General disorders
Frequency: 7 affected / 462 at risk

Adverse event: Tissue disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 462 at risk

Adverse event: Gallbladder disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 462 at risk

Adverse event: Infections - pathogen unspecified
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 462 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 462 at risk

Adverse event: Bone and joint injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 462 at risk

Adverse event: Injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 462 at risk

Adverse event: Medication errors
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 462 at risk

Adverse event: Procedural and device related injuries and complications NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 32 affected / 462 at risk

Adverse event: Cardiac and vascular investigations (excl enzyme tests)
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 462 at risk

Adverse event: Gastrointestinal investigations
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 462 at risk

Adverse event: Diabetic complications
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 462 at risk

Adverse event: Metabolism disorder
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 462 at risk

Adverse event: Musculoskeletal and connective tissue disorders NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 462 at risk

Adverse event: Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 6 affected / 462 at risk

Adverse event: Central nervous system vascular disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 462 at risk

Adverse event: Headaches
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 462 at risk

Adverse event: Increased intracranial pressure and hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 462 at risk

Adverse event: Neurological disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 462 at risk

Adverse event: Renal disorders (excl nephropathies)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 462 at risk

Adverse event: Psychiatric disorders NEC
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 462 at risk

Adverse event: Renal disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 15 affected / 462 at risk

Adverse event: Ureteric disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 462 at risk

Adverse event: Pleural disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 462 at risk

Adverse event: Respiratory disorders NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 462 at risk

Adverse event: Respiratory tract infections
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 462 at risk

Adverse event: Epidermal and dermal conditions
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 462 at risk

Adverse event: Bone and joint therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 462 at risk

Adverse event: Cardiac therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 7 affected / 462 at risk

Adverse event: Head and neck therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 462 at risk

Adverse event: Renal and urinary tract therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 462 at risk

Adverse event: Vascular therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 462 at risk

Adverse event: Aneurysms and artery dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 462 at risk

Adverse event: Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 462 at risk

Adverse event: Vascular disorders NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 462 at risk

Adverse event: Vascular haemorrhagic disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 462 at risk

Adverse event: Anaemias nonhaemolytic and marrow depression
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 462 at risk

Adverse event: Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 462 at risk

Adverse event: Cardiac arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 462 at risk

Adverse event: Cardiac disorder signs and symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 462 at risk

Adverse event: Heart failures
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 462 at risk

Adverse event: Hearing disorders
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 462 at risk

Adverse event: Thyroid disorder
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 462 at risk

Adverse event: Anterior eye structural change, deposit and degeneration
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 462 at risk

Adverse event: Abdominal hernias and other abdominal wall conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 462 at risk

Adverse event: Device issues
Serious: no
Organ System: General disorders
Frequency: 1 affected / 462 at risk

Adverse event: General system disorders NEC
Serious: no
Organ System: General disorders
Frequency: 1 affected / 462 at risk

Adverse event: Bone and joint injuries
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 462 at risk

Adverse event: Injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 462 at risk

Adverse event: Procedural and device related injuries and complications NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 17 affected / 462 at risk

Adverse event: Cardiac and vascular investigations (excl enzyme tests)
Serious: no
Organ System: Investigations
Frequency: 2 affected / 462 at risk

Adverse event: Cardiac disorder signs and symptoms
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 462 at risk

Adverse event: Diabetic complications
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 462 at risk

Adverse event: Metabolism disorder
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 462 at risk

Adverse event: Musculoskeletal and connective tissue disorders NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 462 at risk

Adverse event: Neoplasm
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 462 at risk

Adverse event: Neurological disorders NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 462 at risk

Adverse event: Sleep disturbances (incl subtypes)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 462 at risk

Adverse event: Renal disorder
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 462 at risk

Adverse event: Ureteric disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 462 at risk

Adverse event: Respiratory tract infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 462 at risk

Adverse event: Cardiac therapeutic procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 5 affected / 462 at risk

Adverse event: Aneurysms and artery dissections
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 462 at risk

Adverse event: Anaemias nonhaemolytic and marrow depression
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 455 at risk

Adverse event: Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 455 at risk

Adverse event: Cardiac arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 19 affected / 455 at risk

Adverse event: Cardiac disorder signs and symptoms
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 455 at risk

Adverse event: Cardiac valve disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 455 at risk

Adverse event: Coronary artery disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 455 at risk

Adverse event: Heart failures
Serious: yes
Organ System: Cardiac disorders
Frequency: 73 affected / 455 at risk

Adverse event: Myocardial disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 455 at risk

Adverse event: Surgical and medical procedures
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 455 at risk

Adverse event: Thyroid disorder
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 455 at risk

Adverse event: Anterior eye structural change, deposit and degeneration
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 455 at risk

Adverse event: Abdominal hernias and other abdominal wall conditions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 455 at risk

Adverse event: Gastrointestinal haemorrhages NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 455 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 455 at risk

Adverse event: Gastrointestinal inflammatory conditions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 455 at risk

Adverse event: Gastrointestinal motility and defaecation conditions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 455 at risk

Adverse event: Gastrointestinal signs and symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 455 at risk

Adverse event: Fatal outcome
Serious: yes
Organ System: General disorders
Frequency: 20 affected / 455 at risk

Adverse event: General system disorders NEC
Serious: yes
Organ System: General disorders
Frequency: 8 affected / 455 at risk

Adverse event: Tissue disorders NEC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 455 at risk

Adverse event: Infections - pathogen unspecified
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 455 at risk

Adverse event: Infections and infestations
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 455 at risk

Adverse event: Bone and joint injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 455 at risk

Adverse event: Cardiac disorder signs and symptoms
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 455 at risk

Adverse event: Injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 455 at risk

Adverse event: Procedural and device related injuries and complications NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 26 affected / 455 at risk

Adverse event: Cardiac and vascular investigations (excl enzyme tests)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 455 at risk

Adverse event: Diabetic complications
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 455 at risk

Adverse event: Metabolism disorder
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 455 at risk

Adverse event: Musculoskeletal and connective tissue disorders NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 455 at risk

Adverse event: Neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 8 affected / 455 at risk

Adverse event: Central nervous system vascular disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 455 at risk

Adverse event: Increased intracranial pressure and hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 455 at risk

Adverse event: Sleep disturbances (incl subtypes)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 455 at risk

Adverse event: Psychiatric disorders NEC
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 455 at risk

Adverse event: Renal disorder
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 7 affected / 455 at risk

Adverse event: Ureteric disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 455 at risk

Adverse event: Pleural disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 455 at risk

Adverse event: Respiratory tract infections
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 455 at risk

Adverse event: Epidermal and dermal conditions
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 455 at risk

Adverse event: Skin and subcutaneous tissue disorders NEC
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 455 at risk

Adverse event: Cardiac therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 10 affected / 455 at risk

Adverse event: Vascular therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 455 at risk

Adverse event: Aneurysms and artery dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 455 at risk

Adverse event: Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 455 at risk

Adverse event: Vascular disorders NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 455 at risk

Adverse event: Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 455 at risk

Adverse event: Cardiac arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 455 at risk

Adverse event: Cardiac disorder signs and symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 455 at risk

Adverse event: Coronary artery disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 455 at risk

Adverse event: Heart failures
Serious: no
Organ System: Cardiac disorders
Frequency: 19 affected / 455 at risk

Adverse event: Myocardial disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 455 at risk

Adverse event: Thyroid disorder
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 455 at risk

Adverse event: Infections - pathogen unspecified
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 455 at risk

Adverse event: Abdominal hernias and other abdominal wall conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 455 at risk

Adverse event: Gastrointestinal signs and symptoms
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 455 at risk

Adverse event: General system disorders NEC
Serious: no
Organ System: General disorders
Frequency: 6 affected / 455 at risk

Adverse event: Infections and infestations
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 455 at risk

Adverse event: Procedural and device related injuries and complications NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 455 at risk

Adverse event: Cardiac and vascular investigations (excl enzyme tests)
Serious: no
Organ System: Investigations
Frequency: 3 affected / 455 at risk

Adverse event: Gastrointestinal investigations
Serious: no
Organ System: Investigations
Frequency: 1 affected / 455 at risk

Adverse event: Diabetic complications
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 455 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 455 at risk

Adverse event: Movement disorders (incl parkinsonism)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 455 at risk

Adverse event: Neurological disorders NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 455 at risk

Adverse event: Sleep disturbances (incl subtypes)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 455 at risk

Adverse event: Ureteric disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 455 at risk

Adverse event: Respiratory tract infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 455 at risk

Adverse event: Epidermal and dermal conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 455 at risk

Adverse event: Cardiac therapeutic procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 7 affected / 455 at risk

Adverse event: Head and neck therapeutic procedures
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 455 at risk

Adverse event: Aneurysms and artery dissections
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 455 at risk

Adverse event: Decreased and nonspecific blood pressure disorders and shock
Serious: no
Organ System: Surgical and medical procedures
Frequency: 2 affected / 455 at risk

Adverse event: Vascular disorders NEC
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 455 at risk