Study: NCT00992784

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 180 at risk

Adverse event: Cardiovascular disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 180 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 180 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 180 at risk

Adverse event: Arachnoid cyst
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 180 at risk

Adverse event: Autoimmune thyroiditis
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 180 at risk

Adverse event: Bronchial carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 180 at risk

Adverse event: Ureterolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 180 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 180 at risk

Adverse event: Circulatory collapse
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 180 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 180 at risk

Adverse event: Duodenitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Fibula fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 180 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 180 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Infective exacerbation of chronic obstructive airways diseas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 180 at risk

Adverse event: Meningioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 180 at risk

Adverse event: Patella fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 180 at risk

Adverse event: Pleural mesothelioma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 180 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 180 at risk

Adverse event: Skin ulcer
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 180 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 180 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 180 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pleural effusion was serious adverse event that occured after Day 180.
Frequency: 1 affected / 180 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 78 affected / 180 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 22 affected / 180 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 22 affected / 180 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 23 affected / 180 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 53 affected / 180 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Frequency: 11 affected / 180 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 31 affected / 180 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 37 affected / 180 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 20 affected / 180 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 104 at risk

Adverse event: Cardiovascular disorder
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 104 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 104 at risk

Adverse event: Cholecystitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 104 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 104 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 104 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 104 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 104 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 104 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 104 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 104 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 104 at risk

Adverse event: Vocal cord disorder
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 104 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 12 affected / 103 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 103 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 3 affected / 103 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 103 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 12 affected / 103 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Frequency: 5 affected / 103 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 103 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 103 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 5 affected / 103 at risk

Adverse event: Alcohol poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 86 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 86 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 86 at risk

Adverse event: Myocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 86 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 49 affected / 85 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 85 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 85 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 85 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 21 affected / 85 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Frequency: 4 affected / 85 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 12 affected / 85 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 85 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 5 affected / 85 at risk