Study: NCT00772109

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 953 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 953 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 953 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 953 at risk

Adverse event: Chronic sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 953 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 953 at risk

Adverse event: Gun shot wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 953 at risk

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 953 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 953 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 953 at risk

Adverse event: Bile duct cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 953 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 953 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 953 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 953 at risk

Adverse event: Uterovaginal prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 953 at risk

Adverse event: Bronchitis chronic
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 953 at risk

Adverse event: Arteriovenous fistula
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 953 at risk

Adverse event: Vascular pseudoaneurysm
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 953 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 81 affected / 935 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 716 affected / 936 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 554 affected / 934 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 480 affected / 936 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 447 affected / 936 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 544 affected / 934 at risk

Adverse event: Solicited Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 282 affected / 936 at risk

Adverse event: Solicited Malaise
Serious: no
Organ System: General disorders
Frequency: 212 affected / 936 at risk

Adverse event: Solicited Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 252 affected / 936 at risk

Adverse event: Solicited Shivering
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 71 affected / 936 at risk

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 951 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 951 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 951 at risk

Adverse event: Chest discomfort
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 951 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 951 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 951 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 951 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 951 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 951 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 951 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 951 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 951 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 951 at risk

Adverse event: Carcinoid tumour of the gastrointestinal tract
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 951 at risk

Adverse event: Renal infarct
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 951 at risk

Adverse event: Cystocele
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 951 at risk

Adverse event: Haematoma
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 951 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 82 affected / 935 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 698 affected / 935 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 533 affected / 935 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 449 affected / 935 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 430 affected / 935 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 525 affected / 935 at risk

Adverse event: Solicited Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 279 affected / 935 at risk

Adverse event: Solicited Malaise
Serious: no
Organ System: General disorders
Frequency: 202 affected / 935 at risk

Adverse event: Solicited Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 229 affected / 935 at risk

Adverse event: Solicited Shivering
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 56 affected / 935 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 951 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 951 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 951 at risk

Adverse event: Abscess limb
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 951 at risk

Adverse event: Escherichia sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 951 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 951 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 951 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 951 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 951 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 951 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 951 at risk

Adverse event: Bladder cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 951 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 951 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 951 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 951 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 951 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 97 affected / 929 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 726 affected / 930 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 547 affected / 929 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 500 affected / 931 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 438 affected / 931 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 519 affected / 929 at risk

Adverse event: Solicited Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 314 affected / 930 at risk

Adverse event: Solicited Malaise
Serious: no
Organ System: General disorders
Frequency: 239 affected / 930 at risk

Adverse event: Solicited Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 260 affected / 930 at risk

Adverse event: Solicited Shivering
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 77 affected / 930 at risk

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1421 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 1421 at risk

Adverse event: Bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1421 at risk

Adverse event: Cardiac failure acute
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1421 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1421 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1421 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1421 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1421 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 1421 at risk

Adverse event: Non cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1421 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1421 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1421 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1421 at risk

Adverse event: Sepsi
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1421 at risk

Adverse event: Device occlusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1421 at risk

Adverse event: Wrist fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1421 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1421 at risk

Adverse event: Musculoskeletal chest pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1421 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1421 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1421 at risk

Adverse event: Adenomyosis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1421 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 86 affected / 1392 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 184 affected / 1393 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 139 affected / 1392 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 749 affected / 1394 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 129 affected / 1394 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 117 affected / 1392 at risk

Adverse event: Solicited Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 422 affected / 1394 at risk

Adverse event: Solicited Malaise
Serious: no
Organ System: General disorders
Frequency: 309 affected / 1394 at risk

Adverse event: Solicited Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 430 affected / 1394 at risk

Adverse event: Solicited Shivering
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 87 affected / 1394 at risk