Study: NCT00969332

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Bacteremia, Urosepsis, Fungemia, Viral sepsis - positive culture with symptoms and need for more than 5 days of antibiotics/antifungals
Frequency: 25 affected / 59 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Platelet count less than 20,000K
Frequency: 8 affected / 59 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Change in respiratory status requiring intubation
Frequency: 9 affected / 59 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Cardiac disorders
Notes: Hypotension requiring pressor support.
Frequency: 7 affected / 59 at risk

Adverse event: Increased Creatinine
Serious: yes
Organ System: Renal and urinary disorders
Notes: Requiring need for dialysis.
Frequency: 1 affected / 59 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Bleeding requiring product replacement or medical intervention (does not include pressure or specific medications) or surgical intervention.
Frequency: 10 affected / 59 at risk

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: necrotizing enterocolitis (stage II or III).
Frequency: 1 affected / 59 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Notes: Diagnosis by clinical team
Frequency: 3 affected / 59 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Diagnosis by clinical team and positive urine culture and need for at least 5 days of antibiotics
Frequency: 6 affected / 59 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Notes: EEG or clinical diagnosis
Frequency: 1 affected / 59 at risk

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Change in blood pressure requiring the use of pressor support
Frequency: 3 affected / 59 at risk

Adverse event: Respiratory distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Change in respiratory status requiring intubation or other support.
Frequency: 14 affected / 59 at risk

Adverse event: Hyponatraemia
Serious: no
Organ System: General disorders
Notes: Serum sodium less than 130
Frequency: 11 affected / 59 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: General disorders
Notes: Triglycerides more than 300 mg/dL
Frequency: 3 affected / 59 at risk

Adverse event: Metabolic acidosis
Serious: no
Organ System: General disorders
Notes: potential of hydrogen less than 7.2 and/or requiring medical intervention (volume support, sodium bicarbonate)
Frequency: 6 affected / 59 at risk

Adverse event: Bowel Rejection
Serious: no
Organ System: Gastrointestinal disorders
Notes: Clinical and histological evidence of rejection as well as clinical diagnosis by medical team
Frequency: 1 affected / 59 at risk

Adverse event: Acute Life Threatening Event
Serious: no
Organ System: General disorders
Notes: Diagnosis by clinical team
Frequency: 1 affected / 59 at risk

Adverse event: Increased Creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 59 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Serum glucose \< 60 mg/dL
Frequency: 39 affected / 59 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Notes: Serum glucose \>200 mg/dL
Frequency: 24 affected / 59 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Platelet count \<100,000 cell/cu.mm
Frequency: 28 affected / 59 at risk

Adverse event: Thrombocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Platelet count \>500,000 cu.mm
Frequency: 15 affected / 59 at risk

Adverse event: Leukopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: White blood cell count \<5000 cells/cu.mm
Frequency: 23 affected / 59 at risk

Adverse event: Increased International Normalized Ratio
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: International Normalized Ratio \>1.4
Frequency: 21 affected / 59 at risk

Adverse event: Clinical Bleeding
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 59 at risk