Study: NCT00124709

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 543 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 543 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 543 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 543 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 543 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 543 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 543 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 543 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 543 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 543 at risk

Adverse event: Adenovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 543 at risk

Adverse event: Croup, infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 543 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 543 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 543 at risk

Adverse event: Lymph node abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 543 at risk

Adverse event: Staphylococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 543 at risk

Adverse event: Tonsillitis, streptococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 543 at risk

Adverse event: Varicella
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 543 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 543 at risk

Adverse event: Bronchial hyper-reactivity
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 543 at risk

Adverse event: Asthmatic crisis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 543 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 543 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Acute respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Epiglottic oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 543 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 543 at risk

Adverse event: Hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 543 at risk

Adverse event: Febrile convulsions
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 543 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 543 at risk

Adverse event: Toxicity to various agents
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 543 at risk

Adverse event: Immune thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 543 at risk

Adverse event: Von Willebrand's disease
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 543 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 543 at risk

Adverse event: Metastases to lung
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 543 at risk

Adverse event: Nephroblastoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 543 at risk

Adverse event: Haematuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 543 at risk

Adverse event: Prepuce redundant
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 543 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 288 affected / 543 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 264 affected / 543 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 186 affected / 543 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 76 affected / 543 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 75 affected / 543 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 55 affected / 543 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 52 affected / 543 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 46 affected / 543 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 543 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 45 affected / 543 at risk

Adverse event: Conjunctivitis, bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 39 affected / 543 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 543 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 543 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 543 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 543 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 543 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 187 affected / 543 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 122 affected / 543 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 102 affected / 543 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 68 affected / 543 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 64 affected / 543 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 52 affected / 543 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 543 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 134 affected / 543 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 543 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 140 affected / 543 at risk

Adverse event: Milk allergy
Serious: no
Organ System: Immune system disorders
Frequency: 50 affected / 543 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 123 affected / 543 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 44 affected / 543 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 41 affected / 543 at risk

Adverse event: Conjunctivitis, allergic
Serious: no
Organ System: Eye disorders
Frequency: 76 affected / 543 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 50 affected / 543 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 544 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 544 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 544 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 544 at risk

Adverse event: Respiratory syncytial virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 544 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 544 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 544 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 544 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 544 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 544 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 544 at risk

Adverse event: Beta haemolytic streptococcal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 544 at risk

Adverse event: Eczema, infected
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 544 at risk

Adverse event: Tracheobronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 544 at risk

Adverse event: Pneumonia, bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 544 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 544 at risk

Adverse event: Rotavirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 544 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 544 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 544 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 544 at risk

Adverse event: Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 544 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 544 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 544 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 544 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 544 at risk

Adverse event: Food allergy
Serious: yes
Organ System: Immune system disorders
Frequency: 2 affected / 544 at risk

Adverse event: Milk allergy
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 544 at risk

Adverse event: Febrile convulsions
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 544 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 544 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 544 at risk

Adverse event: Traumatic liver injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 544 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 544 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 544 at risk

Adverse event: Retinal haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 544 at risk

Adverse event: Adverse drug reaction
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 544 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 265 affected / 544 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 260 affected / 544 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 175 affected / 544 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 69 affected / 544 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 61 affected / 544 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 50 affected / 544 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 49 affected / 544 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 51 affected / 544 at risk

Adverse event: Pharyngitis streptococcal
Serious: no
Organ System: Infections and infestations
Frequency: 55 affected / 544 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 544 at risk

Adverse event: Conjunctivitis, bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 45 affected / 544 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 544 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 544 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 33 affected / 544 at risk

Adverse event: Impetigo
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 544 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 29 affected / 544 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 174 affected / 544 at risk

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 107 affected / 544 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 89 affected / 544 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 63 affected / 544 at risk

Adverse event: Asthma
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 53 affected / 544 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 43 affected / 544 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 46 affected / 544 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 135 affected / 544 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 544 at risk

Adverse event: Food allergy
Serious: no
Organ System: Immune system disorders
Frequency: 118 affected / 544 at risk

Adverse event: Milk allergy
Serious: no
Organ System: Immune system disorders
Frequency: 35 affected / 544 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 123 affected / 544 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 46 affected / 544 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 544 at risk

Adverse event: Conjunctivitis, allergic
Serious: no
Organ System: Eye disorders
Frequency: 63 affected / 544 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 44 affected / 544 at risk