Study: NCT00464672

Adverse event: Visual acuity reduced transiently
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 460 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 460 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 460 at risk

Adverse event: Dysentery
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 460 at risk

Adverse event: Ovarian epithelial cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 460 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 460 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 22 affected / 460 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 47 affected / 460 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 27 affected / 460 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 25 affected / 460 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 38 affected / 460 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 117 affected / 460 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 29 affected / 460 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 56 affected / 460 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 32 affected / 460 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 66 affected / 460 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 111 affected / 460 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 460 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 233 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 233 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 18 affected / 233 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 24 affected / 233 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 12 affected / 233 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 15 affected / 233 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 24 affected / 233 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 70 affected / 233 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 15 affected / 233 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 28 affected / 233 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 233 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 38 affected / 233 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 45 affected / 233 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 233 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 400 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 400 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 400 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 18 affected / 400 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 25 affected / 400 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 7 affected / 400 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 9 affected / 400 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 28 affected / 400 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 117 affected / 400 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 28 affected / 400 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 18 affected / 400 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 400 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 35 affected / 400 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 52 affected / 400 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 400 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 11 affected / 199 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 199 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 3 affected / 199 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 1 affected / 199 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 13 affected / 199 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 58 affected / 199 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 14 affected / 199 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 8 affected / 199 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 199 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 25 affected / 199 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 199 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 199 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 402 at risk

Adverse event: Eye injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 402 at risk

Adverse event: Asthmatic crisis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 402 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 18 affected / 402 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 26 affected / 402 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 12 affected / 402 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 26 affected / 402 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 23 affected / 402 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 97 affected / 402 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 34 affected / 402 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 37 affected / 402 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 10 affected / 402 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 34 affected / 402 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 41 affected / 402 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 8 affected / 402 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 199 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 199 at risk

Adverse event: Encephalitis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 199 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 12 affected / 199 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 12 affected / 199 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 7 affected / 199 at risk

Adverse event: Injection site haemorrhage
Serious: no
Organ System: General disorders
Frequency: 13 affected / 199 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 16 affected / 199 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 59 affected / 199 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 20 affected / 199 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 19 affected / 199 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 199 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 199 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 26 affected / 199 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 199 at risk