Study: NCT00319098

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3397 at risk

Adverse event: Anal fissure
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3397 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3397 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 3397 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 3397 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3397 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3397 at risk

Adverse event: Erysipelas
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3397 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3397 at risk

Adverse event: Groin abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3397 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 3397 at risk

Adverse event: Ankle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3397 at risk

Adverse event: Genital injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3397 at risk

Adverse event: Meniscus injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3397 at risk

Adverse event: Intervertebral disc degeneration
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3397 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3397 at risk

Adverse event: Breast cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3397 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 3397 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3397 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 3397 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3397 at risk

Adverse event: Premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 3397 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 3397 at risk

Adverse event: Bartholinís cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3397 at risk

Adverse event: Endometriosis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 3397 at risk

Adverse event: Dermal cyst
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 3397 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: General disorders
Frequency: 320 affected / 3397 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 1150 affected / 3397 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 3037 affected / 3397 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 1277 affected / 3397 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 1107 affected / 3397 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 874 affected / 3397 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1736 affected / 3397 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 466 affected / 3397 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 1566 affected / 3397 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 1670 affected / 3397 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 711 affected / 3397 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 727 affected / 3397 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 405 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 405 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 405 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 405 at risk

Adverse event: Intestinal haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 405 at risk

Adverse event: Oesophageal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 405 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 405 at risk

Adverse event: Anaphylactic shock
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 405 at risk

Adverse event: Mediastinitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 405 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 405 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 405 at risk

Adverse event: Spinal fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 405 at risk

Adverse event: Diabetes mellitus noninsulindependent
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 405 at risk

Adverse event: Ovarian cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 405 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 405 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 405 at risk

Adverse event: Hyperventilation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 405 at risk

Adverse event: Varicose vein
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 405 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: General disorders
Frequency: 29 affected / 405 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 108 affected / 405 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 271 affected / 405 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 165 affected / 405 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 133 affected / 405 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 82 affected / 405 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 117 affected / 405 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 24 affected / 405 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 114 affected / 405 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 124 affected / 405 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 26 affected / 405 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 64 affected / 405 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1136 at risk

Adverse event: Cardiac valve
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1136 at risk

Adverse event: Sinus bradycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1136 at risk

Adverse event: Umbilical hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1136 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1136 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1136 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1136 at risk

Adverse event: Ligament injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1136 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1136 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1136 at risk

Adverse event: Generalised anxiety disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1136 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: General disorders
Frequency: 65 affected / 1136 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 215 affected / 1136 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 748 affected / 1136 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 312 affected / 1136 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 196 affected / 1136 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 130 affected / 1136 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 346 affected / 1136 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 38 affected / 1136 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 350 affected / 1136 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 276 affected / 1136 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 86 affected / 1136 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 134 affected / 1136 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 133 at risk

Adverse event: Macular hole
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 133 at risk

Adverse event: Heat stroke
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 133 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 133 at risk

Adverse event: Vitamin B12 deficiency
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 133 at risk

Adverse event: Lymphoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 133 at risk

Adverse event: Paraesthesia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 133 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: General disorders
Frequency: 5 affected / 133 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Frequency: 19 affected / 133 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 39 affected / 133 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 38 affected / 133 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 17 affected / 133 at risk

Adverse event: Arthralgia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 133 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 24 affected / 133 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 133 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 19 affected / 133 at risk

Adverse event: Myalgia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 133 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 5 affected / 133 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Frequency: 19 affected / 133 at risk