Study: NCT00540592

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 204 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 204 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 204 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 204 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 204 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Assessed between Day 21 and Day 179
Frequency: 2 affected / 204 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 204 at risk

Adverse event: Abdominal adhesions
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 204 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 204 at risk

Adverse event: Atrioventricular block first degree
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 204 at risk

Adverse event: Bifascicular block
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 204 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 204 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 204 at risk

Adverse event: Emphysema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 204 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 204 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 204 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 204 at risk

Adverse event: Postmenopausal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 204 at risk

Adverse event: Prostatic adenoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 204 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 204 at risk

Adverse event: Ulcerative keratitis
Serious: yes
Organ System: Eye disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 204 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 68 affected / 201 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 15 affected / 201 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 13 affected / 201 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 201 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 34 affected / 201 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 22 affected / 201 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 20 affected / 201 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 10 affected / 201 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 13 affected / 201 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 204 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 0 and Day 20
Frequency: 1 affected / 202 at risk

Adverse event: Dyspnoea exertional
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed between Day 0 and Day 20
Frequency: 1 affected / 202 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 0 and Day 20
Frequency: 1 affected / 202 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Assessed between Day 0 and Day 20
Frequency: 1 affected / 202 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 2 affected / 202 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 202 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 202 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 202 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 202 at risk

Adverse event: Gastroenteritis norovirus
Serious: yes
Organ System: Infections and infestations
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 202 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 202 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 202 at risk

Adverse event: Prostate cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 202 at risk

Adverse event: Varicose vein
Serious: yes
Organ System: Vascular disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 202 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 82 affected / 201 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 16 affected / 201 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 12 affected / 201 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 23 affected / 201 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 35 affected / 201 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 38 affected / 201 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 35 affected / 201 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 12 affected / 201 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 18 affected / 201 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 202 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Assessed between Day 0 and Day 20
Frequency: 1 affected / 202 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Assessed between Day 0 and Day 20
Frequency: 1 affected / 202 at risk

Adverse event: Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Assessed between Day 0 and Day 20
Frequency: 1 affected / 202 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 202 at risk

Adverse event: Cholecystitis chronic
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 202 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 202 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 202 at risk

Adverse event: Gout
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 202 at risk

Adverse event: Hypertensive cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 202 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 111 affected / 201 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 37 affected / 201 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 25 affected / 201 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 36 affected / 201 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 54 affected / 201 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 47 affected / 201 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 57 affected / 201 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 19 affected / 201 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 37 affected / 201 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 202 at risk

Adverse event: Goitre
Serious: yes
Organ System: Endocrine disorders
Notes: Assessed between Day 0 and Day 20
Frequency: 1 affected / 202 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Assessed between Day 0 and Day 20
Frequency: 1 affected / 202 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 202 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 202 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 202 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 202 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 202 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 202 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 202 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 202 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 202 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 84 affected / 201 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 12 affected / 201 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 13 affected / 201 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 16 affected / 201 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 35 affected / 201 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 35 affected / 201 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 30 affected / 201 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 10 affected / 201 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 26 affected / 201 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 202 at risk

Adverse event: Plasma cell myeloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Assessed between Day 0 and Day 20
Frequency: 1 affected / 199 at risk

Adverse event: Pancreatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Assessed between Day 0 and Day 20
Frequency: 1 affected / 199 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Bleeding varicose vein
Serious: yes
Organ System: Vascular disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Hypovolaemic shock
Serious: yes
Organ System: Vascular disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 91 affected / 198 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 33 affected / 198 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 18 affected / 198 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 21 affected / 198 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 46 affected / 198 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 39 affected / 198 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 47 affected / 198 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 13 affected / 198 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 18 affected / 198 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 199 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Assessed between Day 0 and Day 20
Frequency: 1 affected / 198 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: Assessed between Day 0 and Day 20
Frequency: 1 affected / 198 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed between Day 0 and Day 20
Frequency: 1 affected / 198 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Notes: Assessed between Day 0 and Day 20
Frequency: 1 affected / 198 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Uterine cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Benign salivary gland neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Vestibular neuronitis
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 119 affected / 197 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 36 affected / 197 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 23 affected / 197 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 45 affected / 198 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 55 affected / 198 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 55 affected / 198 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 66 affected / 198 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 18 affected / 198 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 43 affected / 198 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 198 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 0 and Day 20
Frequency: 1 affected / 198 at risk

Adverse event: Gastric ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Assessed between Day 0 and Day 20
Frequency: 1 affected / 198 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Food poisoning
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Gangrene
Serious: yes
Organ System: Infections and infestations
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Incisional hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Multiple fractures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Osteoporotic fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 198 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 93 affected / 198 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 18 affected / 198 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 11 affected / 198 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 28 affected / 198 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 38 affected / 198 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 36 affected / 198 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 46 affected / 198 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 8 affected / 198 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 17 affected / 198 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 198 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 0 and Day 20
Frequency: 1 affected / 199 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: Assessed between Day 0 and Day 20
Frequency: 1 affected / 199 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed between Day 0 and Day 20
Frequency: 1 affected / 199 at risk

Adverse event: Craniofacial fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Assessed between Day 0 and Day 20
Frequency: 1 affected / 199 at risk

Adverse event: Ischaemic stroke
Serious: yes
Organ System: Nervous system disorders
Notes: Assessed between Day 0 and Day 20
Frequency: 1 affected / 199 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Assessed between Day 0 and Day 20
Frequency: 1 affected / 199 at risk

Adverse event: Post procedural infection
Serious: yes
Organ System: Infections and infestations
Notes: Assessed between Day 0 and Day 20
Frequency: 1 affected / 199 at risk

Adverse event: Skin injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Assessed between Day 0 and Day 20
Frequency: 1 affected / 199 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 3 affected / 199 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 2 affected / 199 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Cervical vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Chronic myeloid leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Hand fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Metastases to central nervous system
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Thyroid neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Vestibular disorder
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 199 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 106 affected / 198 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 34 affected / 198 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 25 affected / 198 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 35 affected / 198 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 63 affected / 198 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 48 affected / 198 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 56 affected / 198 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 14 affected / 198 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 31 affected / 198 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 199 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 200 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 200 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 200 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 200 at risk

Adverse event: Uterine cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 200 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 200 at risk

Adverse event: Biliary colic
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 200 at risk

Adverse event: Chronic myelomonocytic leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 200 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 200 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 200 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 200 at risk

Adverse event: Glaucoma
Serious: yes
Organ System: Eye disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 200 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 200 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 200 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 200 at risk

Adverse event: Neuritis
Serious: yes
Organ System: Nervous system disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 200 at risk

Adverse event: Reversible ischaemic neurological deficit
Serious: yes
Organ System: Nervous system disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 200 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 200 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 200 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 200 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 32 affected / 200 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 200 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 5 affected / 200 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 16 affected / 200 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 24 affected / 200 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 23 affected / 200 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 19 affected / 200 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 6 affected / 200 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 8 affected / 200 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 200 at risk

Adverse event: Jaw fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 203 at risk

Adverse event: Nasal septum deviation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 203 at risk

Adverse event: Panic attack
Serious: yes
Organ System: Psychiatric disorders
Notes: Assessed between Day 21 and Day 179
Frequency: 1 affected / 203 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 93 affected / 201 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 2 affected / 201 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 201 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 201 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 41 affected / 201 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 45 affected / 201 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 40 affected / 201 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 13 affected / 201 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 21 affected / 201 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 203 at risk