Study: NCT01214837

Adverse event: Krabbe's disease
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 242 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 242 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Respiratory synctial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 242 at risk

Adverse event: Staphylococcal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 242 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 242 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 242 at risk

Adverse event: Pneumomediastinum
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 242 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 13 affected / 242 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 42 affected / 242 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 242 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 103 affected / 242 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 242 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 242 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 76 affected / 242 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 140 affected / 242 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 87 affected / 242 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 65 affected / 242 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 137 affected / 242 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 181 affected / 242 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 88 affected / 242 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 34 affected / 242 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 242 at risk

Adverse event: Candida nappy rash
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 242 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 242 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 242 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 94 affected / 242 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 242 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 242 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 242 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 105 affected / 242 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 242 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 242 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 162 affected / 242 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 104 affected / 242 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 242 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 242 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 242 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 10 affected / 242 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 38 affected / 242 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 16 affected / 242 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 29 affected / 242 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 242 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 252 at risk

Adverse event: Abdominal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 252 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 252 at risk

Adverse event: Atypical pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 252 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 252 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 252 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 252 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 252 at risk

Adverse event: Rectal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 252 at risk

Adverse event: Respiratory synctial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 252 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 252 at risk

Adverse event: Nystagmus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 252 at risk

Adverse event: Breath holding
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 252 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 252 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 10 affected / 252 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 25 affected / 252 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 252 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 78 affected / 252 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 252 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 252 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 68 affected / 252 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 138 affected / 252 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 80 affected / 252 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 45 affected / 252 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 140 affected / 252 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 179 affected / 252 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 87 affected / 252 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 252 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 252 at risk

Adverse event: Candida nappy rash
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 252 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 252 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 252 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 77 affected / 252 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 252 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 252 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 252 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 107 affected / 252 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 252 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 252 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 154 affected / 252 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 104 affected / 252 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 32 affected / 252 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 252 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 252 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 11 affected / 252 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 252 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 252 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 31 affected / 252 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 252 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 239 at risk

Adverse event: Congenital megacolon
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 239 at risk

Adverse event: Laryngomalacia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 239 at risk

Adverse event: Anal fissure
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 239 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 239 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 239 at risk

Adverse event: Otitis media acute
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 239 at risk

Adverse event: Pneumonia respiratory syncytial viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 239 at risk

Adverse event: Respiratory synctial virus bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 239 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 239 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 239 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Respiratory acidosis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Sleep apnoea syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 239 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 9 affected / 239 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 40 affected / 239 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 239 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 80 affected / 239 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 239 at risk

Adverse event: Teething
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 239 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 67 affected / 239 at risk

Adverse event: Crying
Serious: no
Organ System: General disorders
Frequency: 112 affected / 239 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 89 affected / 239 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Frequency: 79 affected / 239 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 138 affected / 239 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 157 affected / 239 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 69 affected / 239 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 239 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 239 at risk

Adverse event: Candida nappy rash
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 239 at risk

Adverse event: Croup infectious
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 239 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 239 at risk

Adverse event: Otitis media
Serious: no
Organ System: Infections and infestations
Frequency: 89 affected / 239 at risk

Adverse event: Otitis media acute
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 239 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 239 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 239 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 106 affected / 239 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 30 affected / 239 at risk

Adverse event: Viral rash
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 239 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 158 affected / 239 at risk

Adverse event: Eating disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 93 affected / 239 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 37 affected / 239 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 239 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 16 affected / 239 at risk

Adverse event: Dermatitis atopic
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 239 at risk

Adverse event: Dermatitis diaper
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 22 affected / 239 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 239 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 35 affected / 239 at risk

Adverse event: Candida infection
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 239 at risk