Study: NCT00521053

Adverse event: Left ventricular hypertrophy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 80 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 80 at risk

Adverse event: Injection site oedema
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 80 at risk

Adverse event: Injection site swelling
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 80 at risk

Adverse event: Injection site ulcer
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 80 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 80 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 80 at risk

Adverse event: Injection site necrosis
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 80 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 80 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 80 at risk

Adverse event: Back injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 80 at risk

Adverse event: Delayed recovery from anaesthesia
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 80 at risk

Adverse event: Injection site pain
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 80 at risk

Adverse event: Injection site infection
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 80 at risk

Adverse event: Injection site vesicles
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 80 at risk

Adverse event: Hypothalamo-pituitary disorder
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 80 at risk

Adverse event: Photosensitivity reaction
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 80 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 80 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 80 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 80 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 80 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 80 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 80 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 80 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 80 at risk

Adverse event: Injection site cellulitis
Serious: no
Organ System: General disorders
Frequency: 4 affected / 80 at risk

Adverse event: Injection site discolouration
Serious: no
Organ System: General disorders
Frequency: 25 affected / 80 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 11 affected / 80 at risk

Adverse event: Injection site infection
Serious: no
Organ System: General disorders
Frequency: 5 affected / 80 at risk

Adverse event: Injection site inflammation
Serious: no
Organ System: General disorders
Frequency: 6 affected / 80 at risk

Adverse event: Injection site oedema
Serious: no
Organ System: General disorders
Frequency: 32 affected / 80 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 65 affected / 80 at risk

Adverse event: Injection site photosensitivity reaction
Serious: no
Organ System: General disorders
Frequency: 6 affected / 80 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 17 affected / 80 at risk

Adverse event: Injection site rash
Serious: no
Organ System: General disorders
Frequency: 4 affected / 80 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 20 affected / 80 at risk

Adverse event: Injection site ulcer
Serious: no
Organ System: General disorders
Frequency: 4 affected / 80 at risk

Adverse event: Injection site vesicles
Serious: no
Organ System: General disorders
Frequency: 30 affected / 80 at risk

Adverse event: Injection site warmth
Serious: no
Organ System: General disorders
Frequency: 4 affected / 80 at risk

Adverse event: Lethargy
Serious: no
Organ System: General disorders
Frequency: 4 affected / 80 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 5 affected / 80 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 80 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 80 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 80 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 80 at risk

Adverse event: Musculoskeletal pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 80 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 80 at risk