Study: NCT01021293

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 550 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 550 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 550 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 99 affected / 550 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 32 affected / 550 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 113 affected / 550 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 46 affected / 550 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 140 affected / 550 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Frequency: 154 affected / 550 at risk

Adverse event: Irritability/Fussiness
Serious: no
Organ System: General disorders
Frequency: 244 affected / 550 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 147 affected / 550 at risk

Adverse event: Fever (Axillary)
Serious: no
Organ System: General disorders
Frequency: 99 affected / 550 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 550 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 550 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 550 at risk

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 550 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 550 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 550 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 550 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 550 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 97 affected / 550 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 38 affected / 550 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 125 affected / 550 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Frequency: 156 affected / 550 at risk

Adverse event: Irritability/Fussiness
Serious: no
Organ System: General disorders
Frequency: 216 affected / 550 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 168 affected / 550 at risk

Adverse event: Fever (Axillary)
Serious: no
Organ System: General disorders
Frequency: 71 affected / 550 at risk