Study: NCT00750893

Adverse event: Ileus paralytic
Serious: yes
Organ System: Gastrointestinal disorders
Notes: "Gastro-intestinal system disorders" SOC as per WHO-ART dictionary.
Frequency: 1 affected / 3111 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: "Gastro-intestinal system disorders" SOC as per WHO-ART dictionary.
Frequency: 1 affected / 3111 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: "Resistance mechanism disorders" SOC as per WHO-ART dictionary.
Frequency: 4 affected / 3111 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: "Resistance mechanism disorders" SOC as per WHO-ART dictionary.
Frequency: 1 affected / 3111 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: "Gastro-intestinal system disorders" SOC as per WHO-ART dictionary.
Frequency: 3 affected / 3111 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: "Respiratory system disorders" SOC as per WHO-ART dictionary.
Frequency: 1 affected / 3111 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Notes: "Urinary System Disorders" SOC as per WHO-ART dictionary.
Frequency: 1 affected / 3111 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: "Respiratory system disorders" SOC as per WHO-ART dictionary.
Frequency: 1 affected / 3111 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: "Respiratory system disorders" SOC as per WHO-ART dictionary.
Frequency: 4 affected / 3111 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: "Respiratory system disorders" SOC as per WHO-ART dictionary.
Frequency: 9 affected / 3111 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: "Respiratory system disorders" SOC as per WHO-ART dictionary.
Frequency: 1 affected / 3111 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: "Respiratory system disorders" SOC as per WHO-ART dictionary.
Frequency: 2 affected / 3111 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Gastrointestinal disorders
Notes: "Gastro-intestinal system disorders" SOC as per WHO-ART dictionary.
Frequency: 1 affected / 3111 at risk

Adverse event: Pneumonia viral
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: "Respiratory system disorders" SOC as per WHO-ART dictionary.
Frequency: 1 affected / 3111 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Notes: "Urinary System Disorders" SOC as per WHO-ART dictionary.
Frequency: 3 affected / 3111 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Notes: "Body as a whole - general disorders" SOC as per WHO-ART dictionary.
Frequency: 1 affected / 3111 at risk

Adverse event: Cytomegalovirus gastrointestinal infection
Serious: yes
Organ System: Gastrointestinal disorders
Notes: "Secondary items - events" SOC as per WHO-ART dictionary.
Frequency: 1 affected / 3111 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 204 affected / 3111 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 259 affected / 3111 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 405 affected / 3111 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 200 affected / 3111 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 268 affected / 3111 at risk