Study: NCT02811263

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 37 affected / 257 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Notes: Blood pressure elevated enough to require antihypertensive therapy
Frequency: 7 affected / 257 at risk

Adverse event: Major venous or arterial thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Any thrombosis treated with course of anticoagulation. Any venous or arterial thrombosis involving major vessel not related to a central line. Any symptomatic thrombosis involving major vessel (e.g., symptoms such as superior vena cava syndrome).
Frequency: 6 affected / 257 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Clinical bleeding or oozing requiring transfusion of blood products (e.g., fresh frozen plasma, cryoprecipitate, or platelets).
Frequency: 39 affected / 257 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Cardiac disorders
Notes: Elevated pulmonary vascular resistance treated with inhaled nitric oxide or extracorporeal membrane oxygenation (ECMO) therapy
Frequency: 51 affected / 257 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Intraparenchymal or intraventricular blood visualized by head ultrasound or MRI T1 or T2 sequences.
Frequency: 68 affected / 257 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Clinical code event requiring chest compressions or epinephrine bolus from which the infant recovers (does not lead to death), that is not secondary to endotracheal tube obstruction or other mechanical issue.
Frequency: 3 affected / 257 at risk

Adverse event: Other unexpected life threatening event
Serious: yes
Organ System: General disorders
Notes: Unexpected for hypoxic-ischemic encephalopathy, or unexpected based on the erythropoietin drug profile.
Frequency: 10 affected / 257 at risk

Adverse event: Intubated > 7 days
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 49 affected / 257 at risk

Adverse event: Ever intubated
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 206 affected / 257 at risk

Adverse event: Meconium aspiration system
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 46 affected / 257 at risk

Adverse event: Hypotension warranting inotropes
Serious: no
Organ System: Cardiac disorders
Frequency: 90 affected / 257 at risk

Adverse event: Dysrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 257 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 115 affected / 257 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 24 affected / 257 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 35 affected / 257 at risk

Adverse event: Liver injury
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 125 affected / 257 at risk

Adverse event: Seizure: clinical or electrographic
Serious: no
Organ System: Nervous system disorders
Frequency: 88 affected / 257 at risk

Adverse event: Discharged alive - abnormal neurologic examination
Serious: no
Organ System: Nervous system disorders
Frequency: 50 affected / 257 at risk

Adverse event: Discharged alive - nasal cannula oxygen
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 257 at risk

Adverse event: Discharged alive - tracheostomy or ventilation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 257 at risk

Adverse event: Discharged alive - nasogastric tube feeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 257 at risk

Adverse event: Discharged alive - gastrostomy tube feeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 257 at risk

Adverse event: Discharged alive - failed hearing screening
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 17 affected / 257 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 28 affected / 243 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Cardiac disorders
Notes: Blood pressure elevated enough to require antihypertensive therapy
Frequency: 7 affected / 243 at risk

Adverse event: Major venous or arterial thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Any thrombosis treated with course of anticoagulation. Any venous or arterial thrombosis involving major vessel not related to a central line. Any symptomatic thrombosis involving major vessel (e.g., symptoms such as superior vena cava syndrome).
Frequency: 3 affected / 243 at risk

Adverse event: Disseminated intravascular coagulation
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Clinical bleeding or oozing requiring transfusion of blood products (e.g., fresh frozen plasma, cryoprecipitate, or platelets).
Frequency: 25 affected / 243 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Cardiac disorders
Notes: Elevated pulmonary vascular resistance treated with inhaled nitric oxide or extracorporeal membrane oxygenation (ECMO) therapy
Frequency: 36 affected / 243 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Intraparenchymal or intraventricular blood visualized by head ultrasound or MRI T1 or T2 sequences.
Frequency: 55 affected / 243 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Clinical code event requiring chest compressions or epinephrine bolus from which the infant recovers (does not lead to death), that is not secondary to endotracheal tube obstruction or other mechanical issue.
Frequency: 3 affected / 243 at risk

Adverse event: Other unexpected life threatening event
Serious: yes
Organ System: General disorders
Notes: Unexpected for hypoxic-ischemic encephalopathy, or unexpected based on the erythropoietin drug profile.
Frequency: 6 affected / 243 at risk

Adverse event: Intubated > 7 days
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 38 affected / 243 at risk

Adverse event: Ever intubated
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 195 affected / 243 at risk

Adverse event: Meconium aspiration system
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 49 affected / 243 at risk

Adverse event: Hypotension warranting inotropes
Serious: no
Organ System: Cardiac disorders
Frequency: 73 affected / 243 at risk

Adverse event: Dysrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 243 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 88 affected / 243 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 17 affected / 243 at risk

Adverse event: Acute kidney injury
Serious: no
Organ System: Renal and urinary disorders
Frequency: 23 affected / 243 at risk

Adverse event: Liver injury
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 111 affected / 243 at risk

Adverse event: Seizure: clinical or electrographic
Serious: no
Organ System: Nervous system disorders
Frequency: 97 affected / 243 at risk

Adverse event: Discharged alive - abnormal neurologic examination
Serious: no
Organ System: Nervous system disorders
Frequency: 58 affected / 243 at risk

Adverse event: Discharged alive - nasal cannula oxygen
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 243 at risk

Adverse event: Discharged alive - tracheostomy or ventilation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 243 at risk

Adverse event: Discharged alive - nasogastric tube feeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 243 at risk

Adverse event: Discharged alive - gastrostomy tube feeding
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 243 at risk

Adverse event: Discharged alive - failed hearing screening
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 17 affected / 243 at risk