Study: NCT01011049

Adverse event: Autoimmune thyroiditis
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 507 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 507 at risk

Adverse event: Appendicitis perforated
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 507 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 507 at risk

Adverse event: Pituitary tumor
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 507 at risk

Adverse event: Affective disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 507 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 507 at risk

Adverse event: Embolism venous
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 507 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 507 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 412 affected / 505 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 343 affected / 505 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 310 affected / 505 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 274 affected / 505 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 257 affected / 505 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 53 affected / 505 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 98 affected / 505 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 50 affected / 505 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 20 affected / 505 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 131 affected / 505 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 148 affected / 505 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 252 at risk

Adverse event: Arteriovenous fistula
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 252 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 54 affected / 249 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 45 affected / 249 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 46 affected / 249 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 148 affected / 249 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 32 affected / 249 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 249 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 55 affected / 249 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 15 affected / 249 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 249 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 77 affected / 249 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 65 affected / 249 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 243 at risk

Adverse event: Psychiatric decompensation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 243 at risk

Adverse event: Knee arthroplasty
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 243 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 27 affected / 240 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 13 affected / 240 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 27 affected / 240 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 147 affected / 240 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 240 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 10 affected / 240 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 50 affected / 240 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 19 affected / 240 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 9 affected / 240 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 75 affected / 240 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 72 affected / 240 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 246 at risk

Adverse event: Incisional hernia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 246 at risk

Adverse event: Post procedural complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 246 at risk

Adverse event: Upper limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 246 at risk

Adverse event: Cervix haemorrhage uterine
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 246 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 246 at risk

Adverse event: Spinal operation
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 246 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 183 affected / 245 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 137 affected / 245 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 133 affected / 245 at risk

Adverse event: Injection site pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 145 affected / 245 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 123 affected / 245 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 25 affected / 245 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 54 affected / 245 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 25 affected / 245 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 245 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 68 affected / 245 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 73 affected / 245 at risk