Study: NCT00474266

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 375 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 375 at risk

Adverse event: Medical observation
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 375 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 375 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 375 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 375 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 375 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 375 at risk

Adverse event: Pyelonephritis acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 375 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 375 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 375 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 128 affected / 375 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 210 affected / 375 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 53 affected / 375 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 375 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 54 affected / 375 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 375 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 26 affected / 375 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 375 at risk

Adverse event: Decrease appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 121 affected / 375 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 171 affected / 375 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 112 affected / 375 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 66 affected / 375 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 375 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 125 at risk

Adverse event: Henoch-Schonlein purpura
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 125 at risk

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

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 40 affected / 125 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 56 affected / 125 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 125 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 125 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 125 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 125 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 125 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 125 at risk

Adverse event: Decrease appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 34 affected / 125 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 39 affected / 125 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 31 affected / 125 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 10 affected / 125 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 125 at risk

Adverse event: Poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 374 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 374 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 374 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 374 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 374 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 374 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 374 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 374 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 374 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 104 affected / 374 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 161 affected / 374 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 374 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 374 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 66 affected / 374 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 374 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 374 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 374 at risk

Adverse event: Decrease appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 85 affected / 374 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 136 affected / 374 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 111 affected / 374 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 70 affected / 374 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 374 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 126 at risk

Adverse event: Irritability
Serious: no
Organ System: Psychiatric disorders
Frequency: 58 affected / 126 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 126 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 126 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 126 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 126 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 126 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 126 at risk

Adverse event: Decrease appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 36 affected / 126 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 48 affected / 126 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 22 affected / 126 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 7 affected / 126 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 126 at risk