Study: NCT00666835

Adverse event: Lower respiratory tract and lung infections
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 314 at risk

Adverse event: Bacterial infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 314 at risk

Adverse event: Sepsis, bacteraemia and viraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 314 at risk

Adverse event: Infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 314 at risk

Adverse event: Abdominal and gastrointestinal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 314 at risk

Adverse event: Bone and joint infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 314 at risk

Adverse event: Streptococcal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 314 at risk

Adverse event: Urinary tract infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 314 at risk

Adverse event: Cardiac infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 314 at risk

Adverse event: Influenza viral infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 314 at risk

Adverse event: Pseudomonal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 314 at risk

Adverse event: Skin structures and soft tissue infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 314 at risk

Adverse event: Staphylococcal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 314 at risk

Adverse event: Vascular infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 314 at risk

Adverse event: Viral infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 314 at risk

Adverse event: Cardiac and vascular procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 24 affected / 314 at risk

Adverse event: Lower limb fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 314 at risk

Adverse event: Non-site specific procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 314 at risk

Adverse event: Cerebral injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 314 at risk

Adverse event: Fractures and dislocations NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 314 at risk

Adverse event: Limb injuries NEC (incl traumatic amputation)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 314 at risk

Adverse event: Device related complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 314 at risk

Adverse event: Non-site specific injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 314 at risk

Adverse event: Site specific injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 314 at risk

Adverse event: Upper limb fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 314 at risk

Adverse event: Urinary tract procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 314 at risk

Adverse event: Ischaemic coronary artery disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 17 affected / 314 at risk

Adverse event: Rate and rhythm disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 6 affected / 314 at risk

Adverse event: Heart failures NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 314 at risk

Adverse event: Supraventricular arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 314 at risk

Adverse event: Ventricular arrhythmias and cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 314 at risk

Adverse event: Coronary artery disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 314 at risk

Adverse event: Cardiac disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 314 at risk

Adverse event: Cardiomyopathies
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 314 at risk

Adverse event: Peripheral vasoconstriction, necrosis and vascular insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 8 affected / 314 at risk

Adverse event: Accelerated and malignant hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 5 affected / 314 at risk

Adverse event: Aneurysms and dissections non-site specific
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 314 at risk

Adverse event: Non-site specific necrosis and vascular insufficiency NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 314 at risk

Adverse event: Vascular hypertensive disorders NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 314 at risk

Adverse event: Vascular hypotensive disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 314 at risk

Adverse event: Peripheral embolism and thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 314 at risk

Adverse event: Site specific necrosis and vascular insufficiency NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 314 at risk

Adverse event: Vena caval embolism and thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 314 at risk

Adverse event: Acute and chronic pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 314 at risk

Adverse event: Gastric ulcers and perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 314 at risk

Adverse event: Gastritis (excl infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 314 at risk

Adverse event: Non-site specific gastrointestinal haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 314 at risk

Adverse event: Diverticula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 314 at risk

Adverse event: Gastrointestinal inflammatory disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 314 at risk

Adverse event: Benign neoplasms gastrointestinal (excl oral cavity)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 314 at risk

Adverse event: Dyspeptic signs and symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 314 at risk

Adverse event: Gastrointestinal and abdominal pains (excl oral and throat)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 314 at risk

Adverse event: Gastrointestinal signs and symptoms NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 314 at risk

Adverse event: Gastrointestinal vascular occlusion and infarction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 314 at risk

Adverse event: Haemorrhoids and gastrointestinal varices (excl oesophageal)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 314 at risk

Adverse event: Intestinal ulcers and perforation NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 314 at risk

Adverse event: Peritoneal and retroperitoneal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 314 at risk

Adverse event: Peritoneal and retroperitoneal haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 314 at risk

Adverse event: Bronchospasm and obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 314 at risk

Adverse event: Pneumothorax and pleural effusions NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 314 at risk

Adverse event: Pulmonary oedemas
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 314 at risk

Adverse event: Breathing abnormalities
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 314 at risk

Adverse event: Lower respiratory tract inflammatory and immunologic conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 314 at risk

Adverse event: Respiratory failures (excl neonatal)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 314 at risk

Adverse event: Nasal disorders NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 314 at risk

Adverse event: Parenchymal lung disorders NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 314 at risk

Adverse event: Pulmonary thrombotic and embolic conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 314 at risk

Adverse event: Central nervous system haemorrhages and cerebrovascular accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 314 at risk

Adverse event: Central nervous system vascular disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 314 at risk

Adverse event: Coma states
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 314 at risk

Adverse event: Disturbances in consciousness NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 314 at risk

Adverse event: Mononeuropathies
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 314 at risk

Adverse event: Febrile disorders
Serious: yes
Organ System: General disorders
Notes: General disorders and administrative site conditions
Frequency: 1 affected / 314 at risk

Adverse event: Implant and catheter site reactions
Serious: yes
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 1 affected / 314 at risk

Adverse event: Death and sudden death
Serious: yes
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 1 affected / 314 at risk

Adverse event: General signs and symptoms NEC
Serious: yes
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 1 affected / 314 at risk

Adverse event: Healing abnormal NEC
Serious: yes
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 1 affected / 314 at risk

Adverse event: Colonic neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 314 at risk

Adverse event: Laryngeal neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 314 at risk

Adverse event: Metastases to specified
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 314 at risk

Adverse event: Rectal neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 314 at risk

Adverse event: Respiratory tract small cell carcinomas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 314 at risk

Adverse event: Cholecystitis and cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 314 at risk

Adverse event: Cholestasis and jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 314 at risk

Adverse event: Osteoarthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 314 at risk

Adverse event: Arthropathies NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 314 at risk

Adverse event: Skin and subcutaneous tissue ulcerations
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 314 at risk

Adverse event: Dermal and epidermal conditions NEC
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 314 at risk

Adverse event: Rashes, eruptions and exanthems NEC
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 314 at risk

Adverse event: Renal disorders NEC
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 314 at risk

Adverse event: Arterial therapeutic procedures (excl aortic)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 314 at risk

Adverse event: Vascular therapeutic procedures NEC
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 314 at risk

Adverse event: Joint therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 314 at risk

Adverse event: Hypoglycaemic conditions NEC
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 314 at risk

Adverse event: Calcium metabolism disorders NEC
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 314 at risk

Adverse event: Diabetes mellitus (incl subtypes)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 314 at risk

Adverse event: Total fluid volume increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 314 at risk

Adverse event: Carbohydrate tolerance analyses (incl diabetes)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 314 at risk

Adverse event: ECG investigations
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 314 at risk

Adverse event: Gastrointestinal histopathology procedures
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 314 at risk

Adverse event: Hyperparathyroid disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 314 at risk

Adverse event: Confusion and disorientation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 314 at risk

Adverse event: Depressive disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 314 at risk

Adverse event: Cataracts (excl congenital)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 314 at risk

Adverse event: Transplant rejections
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 314 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 55 affected / 314 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 314 at risk

Adverse event: Haemodialysis complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 49 affected / 314 at risk

Adverse event: Procedural hypotension
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 44 affected / 314 at risk

Adverse event: Procedural hypertension
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 16 affected / 314 at risk

Adverse event: Arteriovenous fistula site complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 18 affected / 314 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 63 affected / 314 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 314 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 314 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 77 affected / 314 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 314 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 314 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 48 affected / 314 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 29 affected / 314 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 29 affected / 314 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 314 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 314 at risk

Adverse event: Lower respiratory tract and lung infections
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 164 at risk

Adverse event: Bacterial infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 164 at risk

Adverse event: Sepsis, bacteraemia and viraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 164 at risk

Adverse event: Infections NEC
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 164 at risk

Adverse event: Bone and joint infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 164 at risk

Adverse event: Upper respiratory tract infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 164 at risk

Adverse event: Cardiac and vascular procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 164 at risk

Adverse event: Non-site specific procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 164 at risk

Adverse event: Cerebral injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 164 at risk

Adverse event: Limb injuries NEC (incl traumatic amputation)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 164 at risk

Adverse event: Device failure and malfunction
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 164 at risk

Adverse event: Thoracic cage fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 164 at risk

Adverse event: Ischaemic coronary artery disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 7 affected / 164 at risk

Adverse event: Rate and rhythm disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 164 at risk

Adverse event: Heart failures NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 164 at risk

Adverse event: Coronary artery disorders NEC
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 164 at risk

Adverse event: Aortic valvular disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 164 at risk

Adverse event: Peripheral vasoconstriction, necrosis and vascular insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 164 at risk

Adverse event: Accelerated and malignant hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 164 at risk

Adverse event: Aneurysms and dissections non-site specific
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 164 at risk

Adverse event: Non-site specific necrosis and vascular insufficiency NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 164 at risk

Adverse event: Vascular hypertensive disorders NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 164 at risk

Adverse event: Vascular hypotensive disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 164 at risk

Adverse event: Haemorrhages NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 164 at risk

Adverse event: Acute and chronic pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Gastric ulcers and perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Gastritis (excl infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 164 at risk

Adverse event: Gastrointestinal inflammatory disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Duodenal ulcers and perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Gastrointestinal spastic and hypermotility disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Inguinal hernias
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Nausea and vomiting symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Bronchospasm and obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Pneumothorax and pleural effusions NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Lower respiratory tract inflammatory and immunologic conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 164 at risk

Adverse event: Central nervous system haemorrhages and cerebrovascular accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 164 at risk

Adverse event: Seizures and seizure disorders NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 164 at risk

Adverse event: Paralysis and paresis (excl congenital and cranial nerve)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 164 at risk

Adverse event: Febrile disorders
Serious: yes
Organ System: General disorders
Notes: General disorders and administrative site conditions
Frequency: 1 affected / 164 at risk

Adverse event: Implant and catheter site reactions
Serious: yes
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 1 affected / 164 at risk

Adverse event: Body temperature perception
Serious: yes
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 1 affected / 164 at risk

Adverse event: Trophic disorders
Serious: yes
Organ System: General disorders
Notes: General disorders and administration site conditions
Frequency: 1 affected / 164 at risk

Adverse event: Renal cell carcinomas
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 164 at risk

Adverse event: Skin neoplasms malignant and unspecified (excl melanoma)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 164 at risk

Adverse event: Soft tissue neoplasms benign NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 164 at risk

Adverse event: Cholecystitis and cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 164 at risk

Adverse event: Osteoarthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 164 at risk

Adverse event: Arthropathies NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 164 at risk

Adverse event: Musculoskeletal and connective tissue signs and symptoms NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 164 at risk

Adverse event: Myopathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 164 at risk

Adverse event: Skin and subcutaneous tissue ulcerations
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 164 at risk

Adverse event: Renal disorders NEC
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 164 at risk

Adverse event: Bladder infections and inflammations
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 164 at risk

Adverse event: Renal obstructive disorders
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 164 at risk

Adverse event: Renal vascular and ischaemic conditions
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 164 at risk

Adverse event: Arterial therapeutic procedures (excl aortic)
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 164 at risk

Adverse event: Anaemias NEC
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 164 at risk

Adverse event: Inner ear signs and symptoms
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 164 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 164 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 164 at risk

Adverse event: Haemodialysis complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 23 affected / 164 at risk

Adverse event: Procedural hypotension
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 23 affected / 164 at risk

Adverse event: Procedural hypertension
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 10 affected / 164 at risk

Adverse event: Arteriovenous fistula site complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 164 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 164 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 164 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 164 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 38 affected / 164 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 164 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 164 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 20 affected / 164 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 9 affected / 164 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 164 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 164 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 164 at risk