Study: NCT00363545

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 22 affected / 636 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 636 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 636 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 636 at risk

Adverse event: Gastro esophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 636 at risk

Adverse event: Asthmatic crisis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 636 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 636 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 636 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 636 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 636 at risk

Adverse event: Enterococcal sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 636 at risk

Adverse event: Escherichia urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 636 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 636 at risk

Adverse event: Infantile spasms
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 636 at risk

Adverse event: Nephropathy toxic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 636 at risk

Adverse event: Omphalitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 636 at risk

Adverse event: Tracheomalacia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 636 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 636 at risk

Adverse event: Cough/runny nose
Serious: no
Organ System: General disorders
Frequency: 335 affected / 636 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 61 affected / 636 at risk

Adverse event: Fever (Rectal)
Serious: no
Organ System: General disorders
Frequency: 405 affected / 636 at risk

Adverse event: Irritability/ Fussiness
Serious: no
Organ System: General disorders
Frequency: 401 affected / 636 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 218 affected / 636 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 162 affected / 636 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 164 affected / 636 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 636 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 20 affected / 638 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 638 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 638 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 638 at risk

Adverse event: Gastro esophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 638 at risk

Adverse event: Asthmatic crisis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 638 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 638 at risk

Adverse event: Bronchial obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 638 at risk

Adverse event: Milk allergy
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 638 at risk

Adverse event: Pertussis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 638 at risk

Adverse event: Sinus tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 638 at risk

Adverse event: Cough/runny nose
Serious: no
Organ System: General disorders
Frequency: 342 affected / 638 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 59 affected / 638 at risk

Adverse event: Fever (Rectal)
Serious: no
Organ System: General disorders
Frequency: 406 affected / 638 at risk

Adverse event: Irritability/ Fussiness
Serious: no
Organ System: General disorders
Frequency: 427 affected / 638 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 234 affected / 638 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 167 affected / 638 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 162 affected / 638 at risk

Adverse event: Bronchiolitis
Serious: no
Organ System: Infections and infestations
Frequency: 48 affected / 638 at risk