Study: NCT01106092

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 78 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 67 affected / 78 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 28 affected / 78 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 33 affected / 78 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 43 affected / 78 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 59 affected / 78 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 53 affected / 78 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 33 affected / 78 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 78 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 78 at risk

Adverse event: Conjunctivitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 78 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 78 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 65 affected / 78 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 29 affected / 78 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 32 affected / 78 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 42 affected / 78 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 60 affected / 78 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 60 affected / 78 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 36 affected / 78 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 78 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 78 at risk

Adverse event: Conjunctivitis bacterial
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 78 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 78 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 66 affected / 78 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 35 affected / 78 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 36 affected / 78 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 46 affected / 78 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 57 affected / 78 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 57 affected / 78 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 36 affected / 78 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 78 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 78 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 78 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 68 affected / 78 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 35 affected / 78 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 35 affected / 78 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 41 affected / 78 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 63 affected / 78 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 65 affected / 78 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 38 affected / 78 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 78 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 78 at risk