Study: NCT00513409

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 84 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 84 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 84 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 84 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 7 affected / 84 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 84 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 84 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 57 affected / 84 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 49 affected / 84 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 44 affected / 84 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 33 affected / 84 at risk

Adverse event: Fever (Rectally)
Serious: no
Organ System: General disorders
Frequency: 30 affected / 84 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 56 affected / 84 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 35 affected / 84 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 84 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 84 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 79 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 79 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 79 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 7 affected / 79 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 79 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 79 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 63 affected / 79 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 52 affected / 79 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 47 affected / 79 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 36 affected / 79 at risk

Adverse event: Fever (Rectally)
Serious: no
Organ System: General disorders
Frequency: 40 affected / 79 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 55 affected / 79 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 37 affected / 79 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 79 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 79 at risk