Study: NCT01511107

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 257 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 257 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 257 at risk

Adverse event: Non-protocol acute otitis media (AOM)
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Non-protocol AOM refers to AOM diagnosed by a non-protocol provider and not confirmed by a protocol provider.
Frequency: 44 affected / 257 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 257 at risk

Adverse event: Protocol defined diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Protocol defined diarrhea is defined as 3 watery stools in 1 day or 2 watery stools for each of 2 consecutive days.
Frequency: 84 affected / 257 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 54 affected / 257 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 44 affected / 257 at risk

Adverse event: Viral illness
Serious: no
Organ System: General disorders
Frequency: 30 affected / 257 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 257 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 257 at risk

Adverse event: Bronchospasm, acute
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: This includes transient episodes of bronchospasm that did not require treatment, as seen in bronchiolitis.
Frequency: 48 affected / 257 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 197 affected / 257 at risk

Adverse event: Diaper dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 166 affected / 257 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash is defined as urticaria or morbilliform or papular rash.
Frequency: 27 affected / 257 at risk

Adverse event: Viral rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 21 affected / 257 at risk

Adverse event: Tympanostomy tube placement
Serious: no
Organ System: Surgical and medical procedures
Frequency: 19 affected / 257 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 258 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 258 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 258 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 258 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 258 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 258 at risk

Adverse event: Non-protocol acute otitis media (AOM)
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Non-protocol AOM refers to AOM diagnosed by a non-protocol provider and not confirmed by a protocol provider.
Frequency: 48 affected / 258 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 258 at risk

Adverse event: Protocol defined diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Protocol defined diarrhea is defined as 3 watery stools in 1 day or 2 watery stools for each of 2 consecutive days.
Frequency: 91 affected / 258 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 51 affected / 258 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 42 affected / 258 at risk

Adverse event: Viral illness
Serious: no
Organ System: General disorders
Frequency: 25 affected / 258 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Frequency: 36 affected / 258 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 258 at risk

Adverse event: Bronchospasm, acute
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: This includes transient episodes of bronchospasm that did not require treatment, as seen in bronchiolitis.
Frequency: 47 affected / 258 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 191 affected / 258 at risk

Adverse event: Diaper dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 155 affected / 258 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash is defined as urticaria or morbilliform or papular rash.
Frequency: 17 affected / 258 at risk

Adverse event: Viral rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 24 affected / 258 at risk

Adverse event: Tympanostomy tube placement
Serious: no
Organ System: Surgical and medical procedures
Frequency: 22 affected / 258 at risk