Study: NCT00197015

Adverse event: Dehydratation
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 324 at risk

Adverse event: Autism spectrum disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 324 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 324 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 324 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 324 at risk

Adverse event: Groin abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 324 at risk

Adverse event: Leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 324 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 324 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 34 affected / 324 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 324 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 324 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 324 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 324 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 324 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 324 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 324 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 95 affected / 304 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 54 affected / 304 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 144 affected / 304 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 94 affected / 304 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 103 affected / 304 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 97 affected / 304 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 45 affected / 304 at risk

Adverse event: Dehydratation
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 455 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 455 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 455 at risk

Adverse event: Burns second degree
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 455 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 455 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 455 at risk

Adverse event: Respiratory syncytial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 455 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 455 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 455 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 455 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 455 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 455 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 79 affected / 455 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 68 affected / 455 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 64 affected / 455 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 39 affected / 455 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 455 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 455 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 22 affected / 455 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 455 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 30 affected / 455 at risk

Adverse event: Papules
Serious: no
Organ System: General disorders
Frequency: 23 affected / 455 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 179 affected / 411 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 110 affected / 411 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 238 affected / 411 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 170 affected / 411 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 162 affected / 411 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 149 affected / 411 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 70 affected / 411 at risk

Adverse event: Dehydratation
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 462 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 462 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 462 at risk

Adverse event: Bronchitis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 462 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 462 at risk

Adverse event: Chemical poisoning
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 462 at risk

Adverse event: Intellectual disability
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 462 at risk

Adverse event: Autism spectrum disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 462 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 462 at risk

Adverse event: Accidental overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 462 at risk

Adverse event: Adenoidal hypertrophy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 462 at risk

Adverse event: Animal bite
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 462 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 462 at risk

Adverse event: Sleep-related breathing disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 462 at risk

Adverse event: Gastroenteritis rotavirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 462 at risk

Adverse event: Localised infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 462 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 462 at risk

Adverse event: Otitis media chronic
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 462 at risk

Adverse event: Subdural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 462 at risk

Adverse event: Sudden death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 462 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 65 affected / 462 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 56 affected / 462 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 58 affected / 462 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 462 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 462 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 23 affected / 462 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 462 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 462 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 462 at risk

Adverse event: Papules
Serious: no
Organ System: General disorders
Frequency: 23 affected / 462 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 178 affected / 424 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 80 affected / 424 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 216 affected / 424 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 154 affected / 424 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 187 affected / 419 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 151 affected / 419 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 82 affected / 419 at risk