Study: NCT00041756

Adverse event: Athralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 77 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 77 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 77 at risk

Adverse event: Appendicitis perforated
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 77 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 77 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 77 at risk

Adverse event: Blood and lymphatic system disorders (Overall)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 77 at risk

Adverse event: Cardiac disorders (Overall)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 77 at risk

Adverse event: Ear and labyrinth disorders (Overall)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 77 at risk

Adverse event: Eye disorders (Overall)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 77 at risk

Adverse event: Gastrointestinal disorders (Overall)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 77 at risk

Adverse event: General disorders and administration site conditions (Overall)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 77 at risk

Adverse event: Infections and infestation (Overall)
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 77 at risk

Adverse event: Injury, poisoning and procedural complications (Overall)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 77 at risk

Adverse event: Investigations (Overall)
Serious: no
Organ System: Investigations
Frequency: 9 affected / 77 at risk

Adverse event: Metabolism and nutrition disorders (Overall)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 77 at risk

Adverse event: Musculoskeletal and connective tissue disorders (Overall)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 37 affected / 77 at risk

Adverse event: Neoplasms benign, malignant and unspecified (Overall)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 77 at risk

Adverse event: Nervous system disorders (Overall)
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 77 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 77 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 77 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 77 at risk

Adverse event: Skin and subcutaneous tissue disorders (Overall)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 77 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 77 at risk

Adverse event: Athralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 80 at risk

Adverse event: Tibia fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 80 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 80 at risk

Adverse event: Dupuytren's contracture
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 80 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 80 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 80 at risk

Adverse event: Vertegrobasilar insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 80 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 80 at risk

Adverse event: Blood and lymphatic system disorders (Overall)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 80 at risk

Adverse event: Cardiac disorders (Overall)
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 80 at risk

Adverse event: Eye disorders (Overall)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 80 at risk

Adverse event: Gastrointestinal disorders (Overall)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 80 at risk

Adverse event: General disorders and administration site conditions (Overall)
Serious: no
Organ System: General disorders
Frequency: 11 affected / 80 at risk

Adverse event: Infections and infestation (Overall)
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 80 at risk

Adverse event: Injury, poisoning and procedural complications (Overall)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 80 at risk

Adverse event: Investigations (Overall)
Serious: no
Organ System: Investigations
Frequency: 16 affected / 80 at risk

Adverse event: Metabolism and nutrition disorders (Overall)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 80 at risk

Adverse event: Musculoskeletal and connective tissue disorders (Overall)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 41 affected / 80 at risk

Adverse event: Neoplasms benign, malignant and unspecified (Overall)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 80 at risk

Adverse event: Nervous system disorders (Overall)
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 80 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 80 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 80 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 80 at risk

Adverse event: Skin and subcutaneous tissue disorders (Overall)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 80 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 80 at risk

Adverse event: Athralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 79 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 79 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 79 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 79 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 79 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 79 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 79 at risk

Adverse event: Biopsy lymph gland abnormal
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 79 at risk

Adverse event: Foot deformity
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 79 at risk

Adverse event: Spinal osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 79 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 79 at risk

Adverse event: Blood and lymphatic system disorders (Overall)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 79 at risk

Adverse event: Cardiac disorders (Overall)
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 79 at risk

Adverse event: Ear and labyrinth disorders (Overall)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 79 at risk

Adverse event: Eye disorders (Overall)
Serious: no
Organ System: Eye disorders
Frequency: 5 affected / 79 at risk

Adverse event: Gastrointestinal disorders (Overall)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 79 at risk

Adverse event: General disorders and administration site conditions (Overall)
Serious: no
Organ System: General disorders
Frequency: 12 affected / 79 at risk

Adverse event: Infections and infestation (Overall)
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 79 at risk

Adverse event: Injury, poisoning and procedural complications (Overall)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 79 at risk

Adverse event: Investigations (Overall)
Serious: no
Organ System: Investigations
Frequency: 12 affected / 79 at risk

Adverse event: Metabolism and nutrition disorders (Overall)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 79 at risk

Adverse event: Musculoskeletal and connective tissue disorders (Overall)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 79 at risk

Adverse event: Neoplasms benign, malignant and unspecified (Overall)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 4 affected / 79 at risk

Adverse event: Nervous system disorders (Overall)
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 79 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 79 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 79 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 79 at risk

Adverse event: Skin and subcutaneous tissue disorders (Overall)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 79 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 79 at risk

Adverse event: Athralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 80 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 80 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 80 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 80 at risk

Adverse event: Atioventricular block NOS
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 80 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 80 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 80 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 80 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 80 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Pain in extremity
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Hepatic cancer metastatic
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 80 at risk

Adverse event: Metastases to bone
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 80 at risk

Adverse event: Ovarian cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 80 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Cardiac disorders (Overall)
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 80 at risk

Adverse event: Ear and labyrinth disorders (Overall)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 4 affected / 80 at risk

Adverse event: Eye disorders (Overall)
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 80 at risk

Adverse event: Gastrointestinal disorders (Overall)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 80 at risk

Adverse event: General disorders and administration site conditions (Overall)
Serious: no
Organ System: General disorders
Frequency: 9 affected / 80 at risk

Adverse event: Infections and infestation (Overall)
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 80 at risk

Adverse event: Injury, poisoning and procedural complications (Overall)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 80 at risk

Adverse event: Investigations (Overall)
Serious: no
Organ System: Investigations
Frequency: 9 affected / 80 at risk

Adverse event: Metabolism and nutrition disorders (Overall)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 80 at risk

Adverse event: Musculoskeletal and connective tissue disorders (Overall)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 43 affected / 80 at risk

Adverse event: Neoplasms benign, malignant and unspecified (Overall)
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 80 at risk

Adverse event: Nervous system disorders (Overall)
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 80 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 80 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 80 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 80 at risk

Adverse event: Skin and subcutaneous tissue disorders (Overall)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 80 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 6 affected / 80 at risk

Adverse event: Athralgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 79 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 79 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 79 at risk

Adverse event: Periarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 79 at risk

Adverse event: Myalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 79 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 79 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 79 at risk

Adverse event: Eosinophilia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 79 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 79 at risk

Adverse event: Erosive duodenitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Gastritis erosive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Fibrosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 79 at risk

Adverse event: Animal bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 79 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 79 at risk

Adverse event: Periostitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 79 at risk

Adverse event: Fibromyalgia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 79 at risk

Adverse event: Tendonitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 79 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 79 at risk

Adverse event: Urethral stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 79 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 79 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 79 at risk

Adverse event: Benign prostatic hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 79 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 79 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 79 at risk

Adverse event: Blood and lymphatic system disorders (Overall)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 79 at risk

Adverse event: Cardiac disorders (Overall)
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 79 at risk

Adverse event: Ear and labyrinth disorders (Overall)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 79 at risk

Adverse event: Eye disorders (Overall)
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 79 at risk

Adverse event: Gastrointestinal disorders (Overall)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 79 at risk

Adverse event: General disorders and administration site conditions (Overall)
Serious: no
Organ System: General disorders
Frequency: 19 affected / 79 at risk

Adverse event: Infections and infestation (Overall)
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 79 at risk

Adverse event: Injury, poisoning and procedural complications (Overall)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 79 at risk

Adverse event: Investigations (Overall)
Serious: no
Organ System: Investigations
Frequency: 10 affected / 79 at risk

Adverse event: Metabolism and nutrition disorders (Overall)
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 79 at risk

Adverse event: Musculoskeletal and connective tissue disorders (Overall)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 44 affected / 79 at risk

Adverse event: Nervous system disorders (Overall)
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 79 at risk

Adverse event: Psychiatric disorders
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 79 at risk

Adverse event: Renal and urinary disorders
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 79 at risk

Adverse event: Respiratory, thoracic and mediastinal disorders
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 79 at risk

Adverse event: Skin and subcutaneous tissue disorders (Overall)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 79 at risk

Adverse event: Vascular disorders
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 79 at risk