Study: NCT00772889

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE was assessed from Day 0 to Day 20
Frequency: 1 affected / 375 at risk

Adverse event: Interstitial lung disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE was assessed from Day 0 to Day 20
Frequency: 1 affected / 375 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE was assessed from Day 0 to Day 20
Frequency: 1 affected / 375 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE was assessed from Day 21-364
Frequency: 3 affected / 375 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Pneumonia bacterial
Serious: yes
Organ System: Infections and infestations
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Scleroderma
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Pneumonia staphylococcal
Serious: yes
Organ System: Infections and infestations
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: SAE was assessed from Day 21-364
Frequency: 2 affected / 375 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE was assessed from Day 21-364
Frequency: 2 affected / 375 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE was assessed from Day 21-364
Frequency: 2 affected / 375 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Ventricular fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Plasma cell myeloma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE was assessed from Day 21-364
Frequency: 3 affected / 375 at risk

Adverse event: Fatigue
Serious: yes
Organ System: General disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Restrictive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Squamous cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE was assessed from Day 21-364
Frequency: 2 affected / 375 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Neuropathy peripheral
Serious: yes
Organ System: Nervous system disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Volvulus
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 375 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 159 affected / 375 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 57 affected / 375 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 23 affected / 375 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 44 affected / 375 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 72 affected / 375 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Frequency: 26 affected / 375 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 54 affected / 375 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 68 affected / 375 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 32 affected / 375 at risk

Adverse event: Peripheral arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Notes: SAE was assessed from Day 0 to Day 20
Frequency: 1 affected / 393 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE was assessed from Day 0 to Day 20
Frequency: 1 affected / 393 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Notes: SAE was assessed from Day 0 to Day 20
Frequency: 1 affected / 393 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Notes: SAE was assessed from Day 0 to Day 20
Frequency: 1 affected / 393 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Coronary artery occlusion
Serious: yes
Organ System: Cardiac disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE was assessed from Day 21-364
Frequency: 2 affected / 393 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: SAE was assessed from Day 21-364
Frequency: 3 affected / 393 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE was assessed from Day 21-364
Frequency: 2 affected / 393 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: SAE was assessed from Day 21-364
Frequency: 2 affected / 393 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: SAE was assessed from Day 21-364
Frequency: 3 affected / 393 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Cystocele
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Osteonecrosis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Haemorrhagic stroke
Serious: yes
Organ System: Nervous system disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Left ventricular failure
Serious: yes
Organ System: Cardiac disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Pulmonary arterial hypertension
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Enterocolitis infectious
Serious: yes
Organ System: Infections and infestations
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Lymphatic fistula
Serious: yes
Organ System: Vascular disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Factor XIII deficiency
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Acetabulum fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Pelvic fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Colon cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE was assessed from Day 21-364
Frequency: 2 affected / 393 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Arterial occlusive disease
Serious: yes
Organ System: Vascular disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Stress cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Aesthesioneuroblastoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Aortic aneurysm
Serious: yes
Organ System: Vascular disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Atrial flutter
Serious: yes
Organ System: Cardiac disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Peptic ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Peripheral artery stenosis
Serious: yes
Organ System: Vascular disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Haemoptysis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Renal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Skin abrasion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 393 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 49 affected / 393 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 10 affected / 393 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 6 affected / 393 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 20 affected / 393 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 37 affected / 393 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Frequency: 18 affected / 393 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 38 affected / 393 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 33 affected / 393 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 16 affected / 393 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE was assessed from Day 21-364
Frequency: 2 affected / 203 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 203 at risk

Adverse event: Gun shot wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE was assessed from Day 21-364
Frequency: 1 affected / 203 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 122 affected / 203 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 9 affected / 203 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 7 affected / 203 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 11 affected / 203 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 39 affected / 203 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Frequency: 9 affected / 203 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 31 affected / 203 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 36 affected / 203 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 10 affected / 203 at risk