Study: NCT01086423

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 330 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 330 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 330 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 330 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 330 at risk

Adverse event: Septic shock
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 330 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 19 affected / 330 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 90 affected / 330 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 28 affected / 330 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 14 affected / 330 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 124 affected / 330 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 171 affected / 330 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 131 affected / 330 at risk

Adverse event: Fever (Axillary)
Serious: no
Organ System: General disorders
Frequency: 217 affected / 330 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 330 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 42 affected / 330 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 324 at risk

Adverse event: Hepatitis neonatal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 324 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 324 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 24 affected / 324 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 91 affected / 324 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 34 affected / 324 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 17 affected / 324 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 102 affected / 324 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 166 affected / 324 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 136 affected / 324 at risk

Adverse event: Fever (Axillary)
Serious: no
Organ System: General disorders
Frequency: 217 affected / 324 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 324 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 46 affected / 324 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 330 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 330 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 330 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 330 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 17 affected / 330 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 102 affected / 330 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Frequency: 26 affected / 330 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 19 affected / 330 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 99 affected / 330 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 163 affected / 330 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 114 affected / 330 at risk

Adverse event: Fever (Axillary)
Serious: no
Organ System: General disorders
Frequency: 183 affected / 330 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 330 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 50 affected / 330 at risk