Study: NCT00377260

Adverse event: Asthma or wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 144 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 144 at risk

Adverse event: Diaper dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 80 affected / 144 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 144 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 144 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 144 at risk

Adverse event: Protocol defined diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: This is defined as 3 watery stools in 1 day or 2 watery stools for each of 2 consecutive days.
Frequency: 36 affected / 144 at risk

Adverse event: Teething
Serious: no
Organ System: General disorders
Frequency: 12 affected / 144 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 33 affected / 144 at risk

Adverse event: Viral rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 144 at risk

Adverse event: Viral illness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 144 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 144 at risk

Adverse event: Mastoiditis
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: One child was diagnosed with an early mastoiditis at the on-therapy visit. Middle ear culture yielded serotype 19A S. pneumoniae. The child was hospitalized and recovered uneventfully.
Frequency: 1 affected / 147 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One child developed pneumonia on study day three. The child was hospitalized and recovered uneventfully. After discharge the mother withdrew from the study. She felt it was too burdensome to complete the memory aid and come for follow-up visits.
Frequency: 1 affected / 147 at risk

Adverse event: Asthma or wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 147 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Eye disorders
Frequency: 11 affected / 147 at risk

Adverse event: Diaper dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 57 affected / 147 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 8 affected / 147 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 147 at risk

Adverse event: Oral candidiasis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 147 at risk

Adverse event: Protocol defined diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: This is defined as 3 watery stools in 1 day or 2 watery stools for each of 2 consecutive days.
Frequency: 24 affected / 147 at risk

Adverse event: Teething
Serious: no
Organ System: General disorders
Frequency: 15 affected / 147 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 34 affected / 147 at risk

Adverse event: Viral illness
Serious: no
Organ System: General disorders
Frequency: 6 affected / 147 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 147 at risk