Study: NCT00894803

Adverse event: Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 25 at risk

Adverse event: Central nervous system vascular disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Communication disorders and disturbances
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 25 at risk

Adverse event: Embolism and thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 25 at risk

Adverse event: Gastrointestinal haemorrhages NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Gastrointestinal signs and symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Muscle disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Neurological disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Neuromuscular disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Pulmonary vascular disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Respiratory disorders NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Vascular haemorrhagic disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 25 at risk

Adverse event: Anxiety disorders and symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 25 at risk

Adverse event: Bacterial infectious disorders
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Body temperature conditions
Serious: no
Organ System: General disorders
Frequency: 3 affected / 25 at risk

Adverse event: Bone, calcium, magnesium and phosphorus metabolism disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 25 at risk

Adverse event: Cardiac arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 25 at risk

Adverse event: Coronary artery disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: Decreased and nonspecific blood pressure disorders and shock
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 25 at risk

Adverse event: Electrolyte and fluid balance conditions
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 25 at risk

Adverse event: Enzyme investigations NEC
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: Epidermal and dermal conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Gastrointestinal motility and defaecation conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Gastrointestinal signs and symptoms
Serious: no
Organ System: General disorders
Frequency: 7 affected / 25 at risk

Adverse event: General system disorders NEC
Serious: no
Organ System: General disorders
Frequency: 4 affected / 25 at risk

Adverse event: Genitourinary tract disorders NEC
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 25 at risk

Adverse event: Haematology investigations (incl blood groups)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 25 at risk

Adverse event: Heart failures
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 25 at risk

Adverse event: Infections - pathogen unspecified
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 25 at risk

Adverse event: Joint disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Lower respiratory tract disorders (excl obstruction and infection)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Muscle disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Musculoskeletal and connective tissue disorders NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 25 at risk

Adverse event: Neurological disorders NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 25 at risk

Adverse event: Procedural related injuries and complications NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 25 at risk

Adverse event: Respiratory disorders NEC
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Seizures (incl subtypes)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Urinary tract signs and symptoms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 25 at risk

Adverse event: White blood cell disorders
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 25 at risk

Adverse event: Anaemias nonhaemolytic and marrow depression
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 101 at risk

Adverse event: Cardiac therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 101 at risk

Adverse event: Central nervous system vascular disorders
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Coronary artery disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 101 at risk

Adverse event: Deliria (incl confusion)
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 101 at risk

Adverse event: Embolism and thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 101 at risk

Adverse event: Gallbladder disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 101 at risk

Adverse event: Gastrointestinal haemorrhages NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 101 at risk

Adverse event: Gastrointestinal inflammatory conditions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: General system disorders NEC
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 101 at risk

Adverse event: Genitourinary tract disorders NEC
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 101 at risk

Adverse event: Heart failures
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 101 at risk

Adverse event: Increased intracranial pressure and hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 101 at risk

Adverse event: Infections - pathogen unspecified
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 101 at risk

Adverse event: Injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 101 at risk

Adverse event: Neurological disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 101 at risk

Adverse event: Pulmonary vascular disorders
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Renal disorders (excl nephropathies)
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 101 at risk

Adverse event: Respiratory disorders NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 101 at risk

Adverse event: Respiratory tract infections
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 101 at risk

Adverse event: Seizures (incl subtypes)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Vascular haemorrhagic disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 101 at risk

Adverse event: Vascular therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 101 at risk

Adverse event: Administration site reactions
Serious: no
Organ System: General disorders
Frequency: 5 affected / 101 at risk

Adverse event: Administration site reactions
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 101 at risk

Adverse event: Allergic conditions
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 101 at risk

Adverse event: Anaemias nonhaemolytic and marrow depression
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 101 at risk

Adverse event: Angioedema and urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 101 at risk

Adverse event: Anxiety disorders and symptoms
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 101 at risk

Adverse event: Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 101 at risk

Adverse event: Body temperature conditions
Serious: no
Organ System: General disorders
Frequency: 7 affected / 101 at risk

Adverse event: Bone, calcium, magnesium and phosphorus metabolism disorders
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 101 at risk

Adverse event: Bronchial disorders (excl neoplasms)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Cardiac arrhythmias
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 101 at risk

Adverse event: Cardiac disorder signs and symptoms
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 101 at risk

Adverse event: Central nervous system vascular disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 101 at risk

Adverse event: Changes in physical activity
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 101 at risk

Adverse event: Cognitive and attention disorders and disturbances
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 101 at risk

Adverse event: Coronary artery disorders
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 101 at risk

Adverse event: Decreased and nonspecific blood pressure disorders and shock
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 101 at risk

Adverse event: Dental and gingival conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 101 at risk

Adverse event: Depressed mood disorders and disturbances
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 101 at risk

Adverse event: Device issues
Serious: no
Organ System: General disorders
Frequency: 1 affected / 101 at risk

Adverse event: Electrolyte and fluid balance conditions
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 16 affected / 101 at risk

Adverse event: Embolism and thrombosis
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 101 at risk

Adverse event: Epidermal and dermal conditions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 101 at risk

Adverse event: Eye disorders NEC
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 101 at risk

Adverse event: Fungal infectious disorders
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 101 at risk

Adverse event: Gastrointestinal motility and defaecation conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 101 at risk

Adverse event: Gastrointestinal signs and symptoms
Serious: no
Organ System: General disorders
Frequency: 15 affected / 101 at risk

Adverse event: General system disorders NEC
Serious: no
Organ System: General disorders
Frequency: 5 affected / 101 at risk

Adverse event: Genitourinary tract disorders NEC
Serious: no
Organ System: Renal and urinary disorders
Frequency: 7 affected / 101 at risk

Adverse event: Glucose metabolism disorders (incl diabetes mellitus)
Serious: no
Organ System: Endocrine disorders
Frequency: 4 affected / 101 at risk

Adverse event: Glucose metabolism disorders (incl diabetes mellitus)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 101 at risk

Adverse event: Haematology investigations (incl blood groups)
Serious: no
Organ System: Investigations
Frequency: 1 affected / 101 at risk

Adverse event: Headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 101 at risk

Adverse event: Increased intracranial pressure and hydrocephalus
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Infections - pathogen unspecified
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 101 at risk

Adverse event: Injuries NEC
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 101 at risk

Adverse event: Joint disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 101 at risk

Adverse event: Lower respiratory tract disorders (excl obstruction and infection)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 101 at risk

Adverse event: Muscle disorders
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 101 at risk

Adverse event: Musculoskeletal and connective tissue disorders NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 101 at risk

Adverse event: Neurological disorders NEC
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 101 at risk

Adverse event: Neuromuscular disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 101 at risk

Adverse event: Penile and scrotal disorders (excl infections and inflammations)
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 101 at risk

Adverse event: Physical examination and organ system status topics
Serious: no
Organ System: Investigations
Frequency: 1 affected / 101 at risk

Adverse event: Pleural disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Renal disorders (excl nephropathies)
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 101 at risk

Adverse event: Respiratory disorders NEC
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 101 at risk

Adverse event: Respiratory tract infections
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 101 at risk

Adverse event: Seizures (incl subtypes)
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 101 at risk

Adverse event: Sleep disorders and disturbances
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 101 at risk

Adverse event: Sleep disturbances (incl subtypes)
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 101 at risk

Adverse event: Tongue conditions
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Upper respiratory tract disorders (excl infections)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 101 at risk

Adverse event: Urinary tract signs and symptoms
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 101 at risk

Adverse event: Urolithiases
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 101 at risk

Adverse event: Vascular haemorrhagic disorders
Serious: no
Organ System: Vascular disorders
Frequency: 12 affected / 101 at risk

Adverse event: Water, electrolyte and mineral investigations
Serious: no
Organ System: Investigations
Frequency: 1 affected / 101 at risk