Study: NCT00427908

Adverse event: Lower limb fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 229 at risk

Adverse event: Bronchitis chronic
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 229 at risk

Adverse event: Stomatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 229 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 229 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 229 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 229 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 229 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 76 affected / 228 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 84 affected / 228 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 36 affected / 228 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 63 affected / 228 at risk

Adverse event: Fever (Rectally)
Serious: no
Organ System: General disorders
Frequency: 36 affected / 228 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 88 affected / 228 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 54 affected / 228 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 15 affected / 229 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 229 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 229 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 229 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 229 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 229 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 229 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 231 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 231 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 231 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 231 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 135 affected / 230 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 97 affected / 230 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 71 affected / 230 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 30 affected / 230 at risk

Adverse event: Fever (Rectally)
Serious: no
Organ System: General disorders
Frequency: 18 affected / 230 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 18 affected / 230 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 16 affected / 230 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 45 affected / 117 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: General disorders
Frequency: 23 affected / 117 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 31 affected / 117 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 12 affected / 231 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 231 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 231 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 231 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 231 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 231 at risk

Adverse event: Bronchitis chronic
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 75 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 75 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 75 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 20 affected / 73 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 24 affected / 73 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 11 affected / 73 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 25 affected / 73 at risk

Adverse event: Fever (Rectally)
Serious: no
Organ System: General disorders
Frequency: 9 affected / 73 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 29 affected / 73 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 17 affected / 73 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 10 affected / 75 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 75 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 75 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 75 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 75 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 75 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 75 at risk

Adverse event: Testicular torsion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 78 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 78 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 60 affected / 78 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 23 affected / 78 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 9 affected / 78 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 5 affected / 78 at risk

Adverse event: Fever (Rectally)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 78 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 11 affected / 78 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 6 affected / 78 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 39 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: General disorders
Frequency: 5 affected / 39 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 39 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 78 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 78 at risk