Study: NCT00568334

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 122 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 122 at risk

Adverse event: Pain (Dose 1)
Serious: no
Organ System: General disorders
Frequency: 13 affected / 121 at risk

Adverse event: Redness (Dose 1)
Serious: no
Organ System: General disorders
Frequency: 33 affected / 121 at risk

Adverse event: Swelling (Dose 1)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 121 at risk

Adverse event: Pain (Dose 2)
Serious: no
Organ System: General disorders
Frequency: 23 affected / 121 at risk

Adverse event: Redness (Dose 2)
Serious: no
Organ System: General disorders
Frequency: 44 affected / 121 at risk

Adverse event: Swelling (Dose 2)
Serious: no
Organ System: General disorders
Frequency: 18 affected / 121 at risk

Adverse event: Fever (Dose 1)
Serious: no
Organ System: General disorders
Frequency: 64 affected / 121 at risk

Adverse event: Fever (Dose 2)
Serious: no
Organ System: General disorders
Frequency: 54 affected / 121 at risk

Adverse event: Bronchitis (Dose 1)
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 122 at risk

Adverse event: Viral infection (Dose 1)
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 122 at risk

Adverse event: Rhinitis (Dose 1)
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 122 at risk

Adverse event: Bronchitis (Dose 2)
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 121 at risk

Adverse event: Viral infection (Dose 2)
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 121 at risk

Adverse event: Rhinitis (Dose 2)
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 121 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 122 at risk

Adverse event: Breath holding
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 122 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 122 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 122 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 122 at risk

Adverse event: Mastoiditis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 122 at risk

Adverse event: Sinusitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 122 at risk

Adverse event: Pain (Dose 1)
Serious: no
Organ System: General disorders
Frequency: 15 affected / 122 at risk

Adverse event: Redness (Dose 1)
Serious: no
Organ System: General disorders
Frequency: 34 affected / 122 at risk

Adverse event: Swelling (Dose 1)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 122 at risk

Adverse event: Pain (Dose 2)
Serious: no
Organ System: General disorders
Frequency: 18 affected / 121 at risk

Adverse event: Redness (Dose 2)
Serious: no
Organ System: General disorders
Frequency: 46 affected / 121 at risk

Adverse event: Swelling (Dose 2)
Serious: no
Organ System: General disorders
Frequency: 14 affected / 121 at risk

Adverse event: Fever (Dose 1)
Serious: no
Organ System: General disorders
Frequency: 52 affected / 122 at risk

Adverse event: Fever (Dose 2)
Serious: no
Organ System: General disorders
Frequency: 53 affected / 121 at risk

Adverse event: Bronchitis (Dose 1)
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 122 at risk

Adverse event: Viral infection (Dose 1)
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 122 at risk

Adverse event: Rhinitis (Dose 1)
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 122 at risk

Adverse event: Bronchitis (Dose 2)
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 121 at risk

Adverse event: Viral infection (Dose 2)
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 121 at risk

Adverse event: Rhinitis (Dose 2)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 121 at risk