Study: NCT02567825

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 129 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 129 at risk

Adverse event: Asthma exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes Asthma exacerbation, Status asthmaticus and Acute bronchospasm
Frequency: 1 affected / 129 at risk

Adverse event: Protocol-defined Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Protocol-defined diarrhea was the occurrence of at least three watery stools on 1 day or at least two watery stools on 2 consecutive days
Frequency: 21 affected / 129 at risk

Adverse event: Diaper dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Diaper dermatitis was defined as dermatitis resulting in topical antifungal treatment.
Frequency: 25 affected / 129 at risk

Adverse event: Tube otorrhea
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 94 affected / 129 at risk

Adverse event: Refractory tube otorrhea
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 129 at risk

Adverse event: Protocol-defined diarrhea
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Protocol-defined diarrhea was the occurrence of at least three watery stools on 1 day or at least two watery stools on 2 consecutive days, resulting in hospitalization
Frequency: 1 affected / 121 at risk

Adverse event: Asthma exacerbation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes Asthma exacerbation, Status asthmaticus and Acute bronchospasm
Frequency: 3 affected / 121 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 121 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 121 at risk

Adverse event: Complex febrile seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 121 at risk

Adverse event: Dehydration
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 121 at risk

Adverse event: Protocol-defined Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Protocol-defined diarrhea was the occurrence of at least three watery stools on 1 day or at least two watery stools on 2 consecutive days
Frequency: 34 affected / 121 at risk

Adverse event: Diaper dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Diaper dermatitis was defined as dermatitis resulting in topical antifungal treatment.
Frequency: 33 affected / 121 at risk

Adverse event: Tube otorrhea
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 34 affected / 121 at risk

Adverse event: Otorrhea, not tube associated
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 8 affected / 121 at risk

Adverse event: Refractory tube otorrhea
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 121 at risk