Study: NCT04397757

Adverse event: Acute CNS Ischemia
Serious: yes
Organ System: Vascular disorders
Notes: Transient ischemic attack; cerebral vascular accident
Frequency: 2 affected / 40 at risk

Adverse event: Altered Mental Status
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Arrhythmia (by ECG or physical examination)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dyspnea or Respiratory Distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 40 at risk

Adverse event: Haemorrhage
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 40 at risk

Adverse event: Albumin, Low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 40 at risk

Adverse event: Alkalosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 40 at risk

Adverse event: Altered Mental Status
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 40 at risk

Adverse event: AST, High
Serious: no
Organ System: Investigations
Frequency: 2 affected / 40 at risk

Adverse event: Blood Pressure Abnormalities Hypertension (with the lowest reading taken after repeat testing durin
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Creatinine, High
Serious: no
Organ System: Investigations
Frequency: 4 affected / 40 at risk

Adverse event: Dyspnea or Respiratory Distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 40 at risk

Adverse event: Fever (non-axillary temperatures only)
Serious: no
Organ System: General disorders
Frequency: 3 affected / 40 at risk

Adverse event: Glucose (mg/dL; mmol/L) Fasting, High
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 40 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: 6 affected / 40 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 40 at risk

Adverse event: Platelets, Decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 40 at risk

Adverse event: Acute CNS Ischemia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 40 at risk

Adverse event: Calcium, Low (mg/dL; mmol/L) >= 7 days of age
Serious: no
Organ System: Investigations
Frequency: 1 affected / 40 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: 4 affected / 40 at risk

Adverse event: Pain (not associated with study agent injections and not specified elsewhere)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 40 at risk

Adverse event: Acute CNS Ischemia
Serious: yes
Organ System: Vascular disorders
Notes: Transient ischemic attack; cerebral vascular accident
Frequency: 1 affected / 39 at risk

Adverse event: Altered Mental Status
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Blood creatinine increased
Serious: yes
Organ System: Investigations
Notes: Creatinine greater than 2x baseline
Frequency: 1 affected / 39 at risk

Adverse event: Blood glucose decreased
Serious: yes
Organ System: Endocrine 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 / 39 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 39 at risk

Adverse event: Pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 39 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 39 at risk

Adverse event: Neurosensory alteration
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 39 at risk

Adverse event: Acidosis
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 39 at risk

Adverse event: Albumin, Low
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 39 at risk

Adverse event: Altered Mental Status
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 39 at risk

Adverse event: Arrhythmia (by ECG or physical examination)
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 39 at risk

Adverse event: AST, High
Serious: no
Organ System: Investigations
Frequency: 2 affected / 39 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 / 39 at risk

Adverse event: Creatinine, High
Serious: no
Organ System: Investigations
Frequency: 5 affected / 39 at risk

Adverse event: Dyspnea or Respiratory Distress
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 39 at risk

Adverse event: Fever (non-axillary temperatures only)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 39 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Glucose (mg/dL; mmol/L) Fasting, High
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 39 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 39 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: 8 affected / 39 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 39 at risk

Adverse event: Platelets, Decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 39 at risk

Adverse event: Proteinuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 39 at risk

Adverse event: Acute CNS Ischemia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 39 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 2 affected / 39 at risk

Adverse event: Calcium, Low (mg/dL; mmol/L) >= 7 days of age
Serious: no
Organ System: Investigations
Frequency: 2 affected / 39 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: 6 affected / 39 at risk

Adverse event: Pain (not associated with study agent injections and not specified elsewhere)
Serious: no
Organ System: General disorders
Frequency: 2 affected / 39 at risk

Adverse event: Pruritus (without skin lesions)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 39 at risk

Adverse event: Thrombosis or Embolism Report only one
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 39 at risk