Study: NCT04388527

Adverse event: Acute CNS Ischemia
Serious: yes
Organ System: Nervous system disorders
Notes: Cerebral vascular accident (e.g., stroke with neurological deficit)
Frequency: 2 affected / 32 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Laboratory Value: Chemistries
Frequency: 1 affected / 32 at risk

Adverse event: Arrhythmia (by ECG or physical examination)
Serious: yes
Organ System: Cardiac disorders
Notes: Life-threatening arrhythmia OR Urgent intervention indicated
Frequency: 2 affected / 32 at risk

Adverse event: Creatinine Clearance Low
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 32 at risk

Adverse event: Dyspnea or Respiratory Distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 32 at risk

Adverse event: Hemorrhage (with significant acute blood loss)
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 32 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 32 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Notes: Life-threatening embolic event (e.g., pulmonary embolism, thrombus)
Frequency: 1 affected / 32 at risk

Adverse event: Altered mental status
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 32 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 32 at risk

Adverse event: Albumin, Low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 32 at risk

Adverse event: Alkalosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 32 at risk

Adverse event: ALT, High
Serious: no
Organ System: Investigations
Frequency: 3 affected / 32 at risk

Adverse event: Altered Mental Status
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 32 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 32 at risk

Adverse event: AST, High
Serious: no
Organ System: Investigations
Frequency: 3 affected / 32 at risk

Adverse event: Blood Pressure Abnormalities Hypertension (with the lowest reading taken after repeat testing durin
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 32 at risk

Adverse event: Calcium, Low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 32 at risk

Adverse event: Creatinine, High
Serious: no
Organ System: Investigations
Frequency: 7 affected / 32 at risk

Adverse event: Fever (non-axillary temperatures only)
Serious: no
Organ System: General disorders
Frequency: 7 affected / 32 at risk

Adverse event: Glucose (mg/dL; mmol/L) Fasting, High
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 32 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 32 at risk

Adverse event: Hemoglobin, Low (g/dL; mmol/L) >= 13 years of age (female only)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 32 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 32 at risk

Adverse event: Lactate, High
Serious: no
Organ System: Investigations
Frequency: 2 affected / 32 at risk

Adverse event: Platelets, Decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 32 at risk

Adverse event: Sodium, High
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 32 at risk

Adverse event: Thrombosis or Embolism
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 32 at risk

Adverse event: Hemorrhage (with significant acute blood loss)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Hemoglobin, Low (g/dL; mmol/L) >= 13 years of age (male only)
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 32 at risk