Study: NCT00529516

Adverse event: Injection site pain
Serious: yes
Organ System: General disorders
Notes: Reported during the active phase of the study (Day 0 - 20)
Frequency: 1 affected / 475 at risk

Adverse event: Ulna fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Reported during the active phase of the study (Day 0 - 20)
Frequency: 1 affected / 475 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 475 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 475 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 475 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 475 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 475 at risk

Adverse event: Alcohol withdrawal syndrome
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 475 at risk

Adverse event: Angina unstable
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 475 at risk

Adverse event: Arthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 475 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Carotid artery stenosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 475 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Cholecystitis infective
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 475 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Hypothyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 475 at risk

Adverse event: Large intestine perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Lung carcinoma cell type unspecified stage III
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 475 at risk

Adverse event: Multiple fractures
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 475 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 475 at risk

Adverse event: Oesophageal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 475 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Sinus node dysfunction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 475 at risk

Adverse event: Spinal fusion surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 475 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 475 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Frequency: 271 affected / 475 at risk

Adverse event: Redness at the injection site
Serious: no
Organ System: General disorders
Frequency: 111 affected / 475 at risk

Adverse event: Swelling at the injection site
Serious: no
Organ System: General disorders
Frequency: 44 affected / 475 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 80 affected / 475 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 131 affected / 475 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 102 affected / 475 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 132 affected / 475 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 35 affected / 475 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 95 affected / 475 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Notes: Reported during the active phase of the study (Day 0 - 20)
Frequency: 1 affected / 488 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Reported during the active phase of the study (Day 0 - 20)
Frequency: 1 affected / 488 at risk

Adverse event: Intervertebral disc degeneration
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Reported during the active phase of the study (Day 0 - 20)
Frequency: 1 affected / 488 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 488 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 488 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 488 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 488 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 488 at risk

Adverse event: Meniscus injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 488 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 488 at risk

Adverse event: Abdominal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 488 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 488 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 488 at risk

Adverse event: Contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 488 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 488 at risk

Adverse event: Cystitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 488 at risk

Adverse event: Diverticulum
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 488 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 488 at risk

Adverse event: Enterovesical fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 488 at risk

Adverse event: Haemothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 488 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 488 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 488 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 488 at risk

Adverse event: Mitral valve incompetence
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 488 at risk

Adverse event: Multiple injuries
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 488 at risk

Adverse event: Pelvi-ureteric obstruction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 488 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 488 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 488 at risk

Adverse event: Precursor B-lymphoblastic lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 488 at risk

Adverse event: Rectal cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 488 at risk

Adverse event: Thoracic vertebral fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 488 at risk

Adverse event: Ventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 488 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 488 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Frequency: 76 affected / 488 at risk

Adverse event: Redness at the injection site
Serious: no
Organ System: General disorders
Frequency: 14 affected / 488 at risk

Adverse event: Swelling at the injection site
Serious: no
Organ System: General disorders
Frequency: 8 affected / 488 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 34 affected / 488 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 46 affected / 488 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 49 affected / 488 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 51 affected / 488 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 23 affected / 488 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 31 affected / 488 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Reported during the active phase of the study (Day 0 - 20)
Frequency: 1 affected / 289 at risk

Adverse event: Meniscus injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 289 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 289 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 289 at risk

Adverse event: Pain at the injection site
Serious: no
Organ System: General disorders
Frequency: 170 affected / 289 at risk

Adverse event: Redness at the injection site
Serious: no
Organ System: General disorders
Frequency: 16 affected / 289 at risk

Adverse event: Swelling at the injection site
Serious: no
Organ System: General disorders
Frequency: 7 affected / 289 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 23 affected / 289 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 71 affected / 289 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 54 affected / 289 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 70 affected / 289 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 17 affected / 289 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 31 affected / 289 at risk