Study: NCT02232399

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: Nodal tachycardia and low cardiac output syndrome postoperatively. Re-operation on the first operative night; Study drug was stopped on the first postoperative night and the patient was excluded from the study
Frequency: 1 affected / 38 at risk

Adverse event: Pericardial fluid and sepsis
Serious: yes
Organ System: Cardiac disorders
Notes: Prolonged hospital stay due to: 1) Operation for pericardial fluid drainage 2) treatment for sepsis with antibiotics
Frequency: 1 affected / 38 at risk

Adverse event: Pericard effusion
Serious: yes
Organ System: Cardiac disorders
Notes: Prolonged hospital stay due to: Pericardiac drainage on postop day 11, due to pericardial effusion
Frequency: 1 affected / 38 at risk

Adverse event: Verified bacterial sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Prolongation of existing hospitalization due to verified bacterial sepsis (Staphylococcus aureus)
Frequency: 1 affected / 38 at risk

Adverse event: Closure of another small VSD + tricuspid valve plasty + permanent pacemaker due to total AV-block
Serious: yes
Organ System: Cardiac disorders
Notes: Prolonged hospital stay due to two re-operations; first for closure of another small VSD and tricuspid valve plastic, and second for inserting permanent pacemaker due to total AV-block.
Frequency: 1 affected / 38 at risk

Adverse event: Readmission for pericardal fluid drainage
Serious: yes
Organ System: Cardiac disorders
Notes: Readmission due to pericardial fluid and re-operation for drainage of the fluid.
Frequency: 1 affected / 38 at risk

Adverse event: Inotropic score > 20
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 38 at risk

Adverse event: Junctional ectopic tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 7 affected / 38 at risk

Adverse event: Readmission
Serious: yes
Organ System: Cardiac disorders
Notes: Readmission on postop day 20 due to common cold and vomiting.
Frequency: 1 affected / 32 at risk

Adverse event: Re-operation and dialysis post re-operation
Serious: yes
Organ System: Cardiac disorders
Notes: Prolonged hospitalisation due to re-operation on postop day 6 and prolonged PICU stay after re-operation. Peritoneal dialysis for total 11 days.
Frequency: 1 affected / 32 at risk

Adverse event: Enalapril caused prolonged hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: Increased creatinine and increased need for diuretics. Patient recovered when enalapril was removed.
Frequency: 1 affected / 32 at risk

Adverse event: Fever and diarrea
Serious: yes
Organ System: Infections and infestations
Notes: Fever and diarrhoea in ward on postoperative day 8. High CRP but negative blood cultures. Was treated as sepsis.
Frequency: 1 affected / 32 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Notes: Prolonged hospital stay due to Upper respiratory infection postoperatively in PICU
Frequency: 1 affected / 32 at risk

Adverse event: AV block III
Serious: yes
Organ System: Cardiac disorders
Notes: AV block III, received permanent pacemaker
Frequency: 1 affected / 32 at risk

Adverse event: Blood culture verified S. aureus sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Prolonged hospitalisation due to blood culture verified S. aureus sepsis.
Frequency: 1 affected / 32 at risk

Adverse event: Postoperative AV-block
Serious: yes
Organ System: Cardiac disorders
Notes: AV-block Episodes postoperatively, received permanent pace-maker 4 months after the operation
Frequency: 1 affected / 32 at risk

Adverse event: hydrocephalus and seizure
Serious: yes
Organ System: Nervous system disorders
Notes: hydrocephalus and bleeding from an old cerebral infarction. Ventriculostomy
Frequency: 1 affected / 32 at risk

Adverse event: Inotropic score > 20
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 32 at risk

Adverse event: Junctional ectopic tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 32 at risk

Adverse event: Third-degree atrioventricular block
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 32 at risk