Study: NCT00892775

Adverse event: Kawasaki's disease
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 332 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 332 at risk

Adverse event: Hypochromic anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 332 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 332 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 332 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 332 at risk

Adverse event: Abdominal discomfort
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 332 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 332 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 332 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 332 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 332 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 332 at risk

Adverse event: Herpangina
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 332 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 332 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 332 at risk

Adverse event: Gastroenteritis salmonella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 332 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 332 at risk

Adverse event: Adenovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 332 at risk

Adverse event: Encephalitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 332 at risk

Adverse event: Enterovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 332 at risk

Adverse event: Exanthema subitum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 332 at risk

Adverse event: Gastroenteritis norovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 332 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 332 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 332 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 332 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 332 at risk

Adverse event: Viral rash
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 332 at risk

Adverse event: Rhinorrhoea; Dose 1
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 31 affected / 332 at risk

Adverse event: Cough; Dose 1
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 332 at risk

Adverse event: Cough; Dose 2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 332 at risk

Adverse event: Rhinorrhoea; Dose 2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 332 at risk

Adverse event: Pain; Dose 1
Serious: no
Organ System: General disorders
Frequency: 62 affected / 330 at risk

Adverse event: Redness; Dose 1
Serious: no
Organ System: General disorders
Frequency: 92 affected / 330 at risk

Adverse event: Swelling; Dose 1
Serious: no
Organ System: General disorders
Frequency: 22 affected / 330 at risk

Adverse event: Pain; Dose 2
Serious: no
Organ System: General disorders
Frequency: 46 affected / 327 at risk

Adverse event: Redness; Dose 2
Serious: no
Organ System: General disorders
Frequency: 79 affected / 327 at risk

Adverse event: Swelling; Dose 2
Serious: no
Organ System: General disorders
Frequency: 37 affected / 327 at risk

Adverse event: Diarrhoea; Dose 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 332 at risk

Adverse event: Rash; Dose 1
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 88 affected / 330 at risk

Adverse event: Rash; Dose 2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 40 affected / 327 at risk

Adverse event: Fever; Dose 1
Serious: no
Organ System: Infections and infestations
Frequency: 231 affected / 330 at risk

Adverse event: Fever; Dose 2
Serious: no
Organ System: Infections and infestations
Frequency: 115 affected / 327 at risk

Adverse event: Upper respiratory tract infection; Dose 1
Serious: no
Organ System: Infections and infestations
Frequency: 50 affected / 332 at risk

Adverse event: Upper respiratory tract infection; Dose 2
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 332 at risk

Adverse event: Band neutrophil count increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 166 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 166 at risk

Adverse event: Conjunctivitis
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 166 at risk

Adverse event: Enterocolitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 166 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 166 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 166 at risk

Adverse event: Balanoposthitis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 166 at risk

Adverse event: Testicular retraction
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 166 at risk

Adverse event: Dermatitis diaper
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 166 at risk

Adverse event: Hypovolaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 166 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 166 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 166 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Herpangina
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Gastroenteritis salmonella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Cellulitis orbital
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 166 at risk

Adverse event: Rhinorrhoea; Dose 1
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 166 at risk

Adverse event: Cough; Dose 1
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 166 at risk

Adverse event: Cough; Dose 2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 166 at risk

Adverse event: Rhinorrhoea; Dose 2
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 166 at risk

Adverse event: Pain; Dose 1
Serious: no
Organ System: General disorders
Frequency: 28 affected / 166 at risk

Adverse event: Redness; Dose 1
Serious: no
Organ System: General disorders
Frequency: 44 affected / 166 at risk

Adverse event: Swelling; Dose 1
Serious: no
Organ System: General disorders
Frequency: 11 affected / 166 at risk

Adverse event: Pain; Dose 2
Serious: no
Organ System: General disorders
Frequency: 24 affected / 164 at risk

Adverse event: Redness; Dose 2
Serious: no
Organ System: General disorders
Frequency: 43 affected / 164 at risk

Adverse event: Swelling; Dose 2
Serious: no
Organ System: General disorders
Frequency: 25 affected / 164 at risk

Adverse event: Diarrhoea; Dose 1
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 166 at risk

Adverse event: Rash; Dose 1
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 42 affected / 166 at risk

Adverse event: Rash; Dose 2
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 164 at risk

Adverse event: Fever; Dose 1
Serious: no
Organ System: Infections and infestations
Frequency: 104 affected / 166 at risk

Adverse event: Fever; Dose 2
Serious: no
Organ System: Infections and infestations
Frequency: 62 affected / 164 at risk

Adverse event: Upper respiratory tract infection; Dose 1
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 166 at risk

Adverse event: Upper respiratory tract infection; Dose 2
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 166 at risk