Study: NCT00970307

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 141 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 141 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 141 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 141 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 141 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 66 affected / 141 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 83 affected / 141 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 64 affected / 141 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 105 affected / 141 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 108 affected / 141 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 72 affected / 141 at risk

Adverse event: Temperature (Axillary)
Serious: no
Organ System: General disorders
Frequency: 53 affected / 141 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 141 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 141 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 141 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 139 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 139 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 70 affected / 139 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 81 affected / 139 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 50 affected / 139 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 91 affected / 139 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 101 affected / 139 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 62 affected / 139 at risk

Adverse event: Temperature (Axillary)
Serious: no
Organ System: General disorders
Frequency: 38 affected / 139 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 139 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 139 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 139 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 141 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 141 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 141 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 85 affected / 141 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 83 affected / 141 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 71 affected / 141 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 107 affected / 141 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 113 affected / 141 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 72 affected / 141 at risk

Adverse event: Temperature (Axillary)
Serious: no
Organ System: General disorders
Frequency: 61 affected / 141 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 141 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 141 at risk