Study: NCT01793129

Adverse event: Arrhythmia needing treatment
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 88 at risk

Adverse event: Intracranial bleeding
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 88 at risk

Adverse event: Persistent metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 88 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 88 at risk

Adverse event: Major Bleeding
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 88 at risk

Adverse event: Cyanosis
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 88 at risk

Adverse event: PPHN
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 88 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 88 at risk

Adverse event: Asphyxial Brain Injury
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 88 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 88 at risk

Adverse event: Death - withdrawal of support
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 88 at risk

Adverse event: Diabetic Cardio-Myopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 88 at risk

Adverse event: Blood immunoglobulin E increased
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: HIE HYPOXIC ISCHEMIC ENCEPHALOPATHY
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: HIE with out come of Death
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 88 at risk

Adverse event: Neonatal Encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Neonatal insult
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Severe HIE
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Severe hypoxic ischemic brain
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Withdrawal of Support/Death
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 88 at risk

Adverse event: Hyperphosphataemia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 88 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: multiorgan failure and withdrawl of support
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 88 at risk

Adverse event: pleural effusion/pneumothorax
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 88 at risk

Adverse event: Persistent metabolic acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 88 at risk

Adverse event: Intracranial bleeding
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 88 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 88 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 88 at risk

Adverse event: PPHN
Serious: no
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 88 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 15 affected / 88 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 88 at risk

Adverse event: Intracranial bleeding
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 78 at risk

Adverse event: Persistent metabolic acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 78 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 9 affected / 78 at risk

Adverse event: Major Bleeding
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 78 at risk

Adverse event: PPHN
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 78 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 78 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 78 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 78 at risk

Adverse event: Death secondary to severe HIE
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Blood immunoglobulin E increased
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 78 at risk

Adverse event: Hyperkalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 78 at risk

Adverse event: Illeal perforation; small bowl resectioned
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Spontaneous intestinal perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Hypoxic-ischaemic encephalopathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Arrhythmia needing treatment
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 78 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 78 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 78 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 78 at risk

Adverse event: Bilateral mIneralizing vasculopathy
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 78 at risk