Study: NCT00659789

Adverse event: Appendicitis perforated
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Perforated appendix
Frequency: 1 affected / 93 at risk

Adverse event: Multiple sclerosis
Serious: yes
Organ System: Nervous system disorders
Notes: Multiple sclerosis
Frequency: 1 affected / 93 at risk

Adverse event: Cellulitis of male external genital organ
Serious: yes
Organ System: Infections and infestations
Notes: Cellulitis of scrotum and penis
Frequency: 1 affected / 93 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Notes: Acute appendicitis resulting in appendectomy
Frequency: 1 affected / 93 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Notes: Surgical wound infection
Frequency: 1 affected / 93 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: Injection site erythema
Frequency: 62 affected / 93 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 39 affected / 93 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 35 affected / 93 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 11 affected / 93 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 16 affected / 93 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 7 affected / 93 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 15 affected / 93 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 93 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 93 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 93 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 93 at risk

Adverse event: Influenza-like illness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 93 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 93 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 4 affected / 93 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 93 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 93 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 93 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 93 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 93 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 93 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 93 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 93 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 93 at risk

Adverse event: Necrosis
Serious: yes
Organ System: General disorders
Notes: Atypic(al) necrosis of both femoral heads
Frequency: 1 affected / 42 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Notes: Bipolar disorder resulting in hospitalization
Frequency: 1 affected / 42 at risk

Adverse event: Procedural dizziness
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Prolonged anesthesia effects (dizziness)
Frequency: 1 affected / 42 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Notes: Injection site erythema
Frequency: 6 affected / 42 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 6 affected / 42 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 42 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 6 affected / 42 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 3 affected / 42 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 42 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 42 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Influenza-like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 1 affected / 42 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Night sweats
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 42 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 42 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 42 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 42 at risk