Study: NCT00321373

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE reported from Day 0 to Day 30.
Frequency: 1 affected / 407 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE reported from Day 0 to Day 30.
Frequency: 1 affected / 407 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE reported from Day 0 to Day 30.
Frequency: 1 affected / 407 at risk

Adverse event: Injection site erythema
Serious: yes
Organ System: General disorders
Notes: SAE reported from Day 0 to Day 30.
Frequency: 1 affected / 407 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: SAE reported from Day 0 to Day 30.
Frequency: 1 affected / 407 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Notes: SAE reported from Day 30 to Day 180.
Frequency: 2 affected / 407 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 407 at risk

Adverse event: Arthralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 407 at risk

Adverse event: Brain stem thrombosis
Serious: yes
Organ System: Nervous system disorders
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 407 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 407 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 80 affected / 407 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 149 affected / 407 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 21 affected / 407 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 104 affected / 407 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Frequency: 129 affected / 407 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 95 affected / 407 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: General disorders
Frequency: 28 affected / 407 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 246 affected / 407 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 95 affected / 407 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 84 affected / 407 at risk

Adverse event: Generalised tonic-clonic seizure
Serious: yes
Organ System: Nervous system disorders
Notes: SAE reported from Day 0 to Day 30.
Frequency: 1 affected / 406 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 406 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 406 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 406 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 406 at risk

Adverse event: Irritable bowel syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 406 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 406 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 406 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 406 at risk

Adverse event: Peptic ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 406 at risk

Adverse event: Polymyalgia rheumatica
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 406 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 406 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 406 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 406 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 406 at risk

Adverse event: Uterine neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 406 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 17 affected / 406 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 42 affected / 406 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 406 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 51 affected / 406 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Frequency: 31 affected / 406 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 19 affected / 406 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: General disorders
Frequency: 20 affected / 406 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 32 affected / 406 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 50 affected / 406 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 8 affected / 406 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE reported from Day 0 to Day 30.
Frequency: 1 affected / 407 at risk

Adverse event: Pancreatic neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE reported from Day 0 to Day 30.
Frequency: 1 affected / 407 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE reported from Day 0 to Day 30.
Frequency: 1 affected / 407 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 407 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 407 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 407 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 407 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 407 at risk

Adverse event: Dermatitis allergic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 407 at risk

Adverse event: Drowning
Serious: yes
Organ System: General disorders
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 407 at risk

Adverse event: Extrasystoles
Serious: yes
Organ System: Cardiac disorders
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 407 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 407 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 407 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: SAE reported from Day 30 to Day 180.
Frequency: 1 affected / 407 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 21 affected / 407 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 47 affected / 407 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 407 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 53 affected / 407 at risk

Adverse event: Muscle aches
Serious: no
Organ System: General disorders
Frequency: 38 affected / 407 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 26 affected / 407 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: General disorders
Frequency: 19 affected / 407 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 86 affected / 407 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 65 affected / 407 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 50 affected / 407 at risk