Study: NCT00136604

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 249 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 249 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 249 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 249 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 130 affected / 249 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 142 affected / 249 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 198 affected / 249 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 206 affected / 249 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 135 affected / 249 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 159 affected / 249 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 114 affected / 249 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 249 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 54 affected / 123 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 68 affected / 123 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 89 affected / 123 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 90 affected / 123 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 57 affected / 123 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 71 affected / 123 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 48 affected / 123 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 123 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 79 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 79 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 44 affected / 79 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 58 affected / 79 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 61 affected / 79 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 43 affected / 79 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 46 affected / 79 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 38 affected / 79 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 79 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 19 affected / 41 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 41 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 29 affected / 41 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 31 affected / 41 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 20 affected / 41 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 41 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 20 affected / 41 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 125 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 57 affected / 125 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 55 affected / 125 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 79 affected / 125 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 87 affected / 125 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 56 affected / 125 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 58 affected / 125 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 51 affected / 125 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 125 at risk