Study: NCT02361944

Adverse event: Category: Arrythmia, Pacemaker or Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 100 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 100 at risk

Adverse event: Surgical complications requiring valve replacement revision
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 100 at risk

Adverse event: Severe postoperative hallucinations
Serious: yes
Organ System: Psychiatric disorders
Notes: 4-5 days of vivid dreams and visual and auditory hallucinations
Frequency: 1 affected / 100 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Immune system disorders
Notes: Temperature \> 38.0 degrees Celsius
Frequency: 9 affected / 100 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Heart rate \> 120 bpm
Frequency: 5 affected / 100 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Mean arterial blood pressure \< 60 mmHg
Frequency: 29 affected / 100 at risk

Adverse event: Vasoplegia
Serious: no
Organ System: Vascular disorders
Notes: Norepinephrine dose \> 5 ug/min
Frequency: 34 affected / 100 at risk

Adverse event: Decreased cardiac output
Serious: no
Organ System: Cardiac disorders
Notes: Cardiac index \< 2.0 L/min/m2
Frequency: 2 affected / 100 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Hematocrit \< 30%
Frequency: 49 affected / 100 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: White blood cell count \> 15,000
Frequency: 37 affected / 100 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Platelet count \< 50,000
Frequency: 1 affected / 100 at risk

Adverse event: Category: Arrythmia, Pacemaker or Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 5 affected / 100 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: refractory postoperative hypoxia requiring ECMO.
Frequency: 1 affected / 100 at risk

Adverse event: Right ventricular failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Heparin-induced thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Re-accumulation of moderate to large pleural effusion requiring reinsertion of chest tube
Frequency: 1 affected / 100 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 100 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Immune system disorders
Notes: Temperature \> 38.0 degrees Celsius
Frequency: 6 affected / 100 at risk

Adverse event: Tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Heart rate \> 120 bpm
Frequency: 8 affected / 100 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Mean arterial blood pressure \< 60 mmHg
Frequency: 25 affected / 100 at risk

Adverse event: Vasoplegia
Serious: no
Organ System: Vascular disorders
Notes: Norepinephrine dose \> 5 ug/min
Frequency: 28 affected / 100 at risk

Adverse event: Decreased cardiac output
Serious: no
Organ System: Cardiac disorders
Notes: Cardiac index \< 2.0 L/min/m2
Frequency: 5 affected / 100 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Hematocrit \< 30%
Frequency: 48 affected / 100 at risk

Adverse event: Leukocytosis
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: White blood cell count \> 15,000
Frequency: 47 affected / 100 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Platelet count \< 50,000
Frequency: 1 affected / 100 at risk