Study: NCT00630331

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Hyperthyroidism
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Peritoneal cyst
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Cholangitis sclerosing
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Hepatitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Acute sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3813 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3813 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3813 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3813 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3813 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3813 at risk

Adverse event: Lung abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3813 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3813 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3813 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3813 at risk

Adverse event: Alcohol poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3813 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3813 at risk

Adverse event: Extradural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3813 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3813 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3813 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3813 at risk

Adverse event: Obesity
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3813 at risk

Adverse event: Bone neoplasm
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3813 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3813 at risk

Adverse event: Delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3813 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3813 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Polycystic ovaries
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Uterine haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Nasal septum deviation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Tonsillar hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Aortic valve replacement
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3813 at risk

Adverse event: Appendicetomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3813 at risk

Adverse event: Knee operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3813 at risk

Adverse event: Tendon operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3813 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3813 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 212 affected / 3813 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 390 affected / 3813 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 510 affected / 3813 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 239 affected / 3813 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1158 affected / 3813 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 218 affected / 3813 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 290 affected / 3813 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 451 affected / 3813 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 571 affected / 3813 at risk

Adverse event: Vertigo positional
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 3669 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3669 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3669 at risk

Adverse event: Anal fistula
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3669 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3669 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3669 at risk

Adverse event: Intestinal Obstructon
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3669 at risk

Adverse event: Morning sickness
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3669 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3669 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3669 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3669 at risk

Adverse event: Perirectal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3669 at risk

Adverse event: Peritonsillar abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3669 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3669 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3669 at risk

Adverse event: Abdominal injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3669 at risk

Adverse event: Foot fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3669 at risk

Adverse event: Joint injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3669 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3669 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3669 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3669 at risk

Adverse event: Wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3669 at risk

Adverse event: Ovarian cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3669 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3669 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3669 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3669 at risk

Adverse event: Acute stress disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3669 at risk

Adverse event: Major depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3669 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3669 at risk

Adverse event: Dysuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3669 at risk

Adverse event: Haemorrhagic ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 3669 at risk

Adverse event: Nasal septum deviation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 3669 at risk

Adverse event: Homicide
Serious: yes
Organ System: Social circumstances
Frequency: 1 affected / 3669 at risk

Adverse event: Medical device removal
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3669 at risk

Adverse event: Nasal septal operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3669 at risk

Adverse event: Rhinoplasty
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3669 at risk

Adverse event: Thrombophlebitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3669 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 212 affected / 3669 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 404 affected / 3669 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 492 affected / 3669 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 207 affected / 3669 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 893 affected / 3669 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 181 affected / 3669 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 260 affected / 3669 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 369 affected / 3669 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 554 affected / 3669 at risk

Adverse event: Coronary artery disease
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3894 at risk

Adverse event: Mydriasis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 3894 at risk

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3894 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3894 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3894 at risk

Adverse event: Salivary duct inflammation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3894 at risk

Adverse event: Salivary gland calculus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3894 at risk

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3894 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3894 at risk

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 3894 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3894 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 3894 at risk

Adverse event: Breast cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3894 at risk

Adverse event: Mastitis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3894 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3894 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 3894 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3894 at risk

Adverse event: Chest injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3894 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3894 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 3894 at risk

Adverse event: Adenocarcinoma of the cervix
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3894 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3894 at risk

Adverse event: Carcinoid tumour
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3894 at risk

Adverse event: Leiomyosarcoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3894 at risk

Adverse event: Cerebral haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3894 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3894 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3894 at risk

Adverse event: Tethered cord syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3894 at risk

Adverse event: Anxiety
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3894 at risk

Adverse event: Borderline personality disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3894 at risk

Adverse event: Cystocele
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 3894 at risk

Adverse event: Breast hyperplasia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3894 at risk

Adverse event: Dysmenorrhoea
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3894 at risk

Adverse event: Menometrorrhagia
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3894 at risk

Adverse event: Pelvic pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3894 at risk

Adverse event: Dermatitis atopic
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3894 at risk

Adverse event: Appendicetomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 3894 at risk

Adverse event: Varicose vein
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3894 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 225 affected / 3894 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 386 affected / 3894 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 391 affected / 3894 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 101 affected / 3894 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 375 affected / 3894 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 103 affected / 3894 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 238 affected / 3894 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 278 affected / 3894 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 597 affected / 3894 at risk