Study: NCT01756040

Adverse event: Progressive hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 211 at risk

Adverse event: Intraventricular hemorrhage, Grade IV
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 211 at risk

Adverse event: Intraventricular hemorrhage, Grade III
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 211 at risk

Adverse event: Pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 211 at risk

Adverse event: pulmonary interstitial emphysema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 211 at risk

Adverse event: Worsening respiratory status
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: worsening respiratory status requiring increased support such as intubation and mechanical ventilation
Frequency: 3 affected / 211 at risk

Adverse event: Patent ductus arteriosus
Serious: yes
Organ System: Cardiac disorders
Notes: patent ductus arteriosus that was treated with medication (e.g. indomethacin)
Frequency: 4 affected / 211 at risk

Adverse event: Spontaneous intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 211 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Direct conjugated bilirubin \>2.0 mg/dL
Frequency: 1 affected / 211 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: culture-confirmed bloodstream infection (sepsis)
Frequency: 4 affected / 211 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Culture-confirmed urinary tract infection
Frequency: 1 affected / 211 at risk

Adverse event: Pleocytosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Elevated WBC count (severity IV)
Frequency: 1 affected / 211 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: low white blood cell count \<2000
Frequency: 1 affected / 211 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Serum calcium \>12.2 meq/L
Frequency: 1 affected / 211 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Serum potassium ≥6.9
Frequency: 2 affected / 211 at risk

Adverse event: Metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Serum bicarbonate \<15 meq/L
Frequency: 2 affected / 211 at risk

Adverse event: Pulmonary haemorrhage
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 211 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: vomiting \<5 episodes/day
Frequency: 10 affected / 211 at risk

Adverse event: low serum bicarbonate
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Serum bicarbonate 15-21 meq/L
Frequency: 23 affected / 211 at risk

Adverse event: Hyperkalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Serum potassium \>5.5 and \<6.9
Frequency: 14 affected / 211 at risk

Adverse event: Elevated BUN
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Blood urea nitrogen (BUN) \>27 and \<59 meq/L
Frequency: 11 affected / 211 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: hematocrit \<35 and \>25
Frequency: 11 affected / 211 at risk