Study: NCT04767061

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Grade 1 (Adult: Systolic BP 120 - 139 mm Hg or diastolic BP 80 - 89 mm Hg; Pediatric: Systolic/diastolic BP \>90th percentile but\< 95th percentile; Adolescent: BP ≥120/80 even if \< 95th percentile) / Possibly related to the research.
Frequency: 1 affected / 9 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 (Mild unsteadiness or sensation of movement) / Possibly related to the research.
Frequency: 3 affected / 9 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: Grade 1 (Asymptomatic, intervention not indicated) / Not related to the research.
Frequency: 2 affected / 9 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Grade 1 (Asymptomatic, intervention not indicated) / Possibly related to the research.
Frequency: 5 affected / 9 at risk

Adverse event: Eye disorders - other, specify
Serious: no
Organ System: Eye disorders
Notes: Grade 2 (Loss of Central Vision of Left Eye; Moderate; minimal, local or noninvasive intervention indicated; limiting instrumental ADL; best corrected visual acuity 20/40 and better or 3 lines or less dec vision from baseline) / Not related to study.
Frequency: 1 affected / 9 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 1 (Fatigue relieved by rest) / Possibly related to the research.
Frequency: 2 affected / 9 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: Grade 1 (Mild symptoms; intervention not indicated) / Depending on subject and instance, possibly related or not related to the research.
Frequency: 1 affected / 9 at risk

Adverse event: Cardiac failure
Serious: no
Organ System: Cardiac disorders
Notes: Grade 1 (Heart Failure Exacerbation - Asymptomatic with laboratory (e.g., BNP \[B-Natriuretic Peptide \]) or cardiac imaging abnormalities) / Not related to the study
Frequency: 1 affected / 9 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Grade 1 (Adult: Systolic BP 120 - 139 mm Hg or diastolic BP 80 - 89 mm Hg; Pediatric: Systolic/diastolic BP \>90th percentile but\< 95th percentile; Adolescent: BP ≥120/80 even if \< 95th percentile) / Possibly related to the research.
Frequency: 2 affected / 9 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 (Mild unsteadiness or sensation of movement) / Possibly related to the research.
Frequency: 1 affected / 9 at risk

Adverse event: Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: Grade 1 (Asymptomatic, intervention not indicated) / Not related to the research.
Frequency: 1 affected / 9 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Grade 1 (Asymptomatic, intervention not indicated) / Possibly related to the research.
Frequency: 5 affected / 9 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 1 (Shortness of breath with moderate exertion) / Possibly related to the research.
Frequency: 1 affected / 9 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Notes: Grade 2 (Symptomatic; non-urgent medical intervention indicated) / Possibly related to the research.
Frequency: 3 affected / 9 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Notes: Grade 1 (Mild symptoms; intervention not indicated) / Depending on subject and instance, possibly related or not related to the research.
Frequency: 2 affected / 9 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 4 (Heart Failure Exacerbation; Life-threatening consequences; urgent intervention indicated (e.g., continuous IV therapy or mechanical hemodynamic support)) / Possibly related to the research.
Frequency: 1 affected / 9 at risk

Adverse event: Hypoxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Grade 4 (Life-threatening airway compromise; urgent intervention indicated (e.g., tracheotomy or intubation)) / Not related to the research.
Frequency: 1 affected / 9 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: Grade 4 (Life-threatening consequences; urgent intervention indicated) / Not related to the research.
Frequency: 1 affected / 9 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Notes: Grade 4 (Life-threatening consequences and urgent intervention indicated) / Possibly related to the research.
Frequency: 1 affected / 9 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Notes: Grade 1 (Adult: Systolic BP 120 - 139 mm Hg or diastolic BP 80 - 89 mm Hg; Pediatric: Systolic/diastolic BP \>90th percentile but\< 95th percentile; Adolescent: BP ≥120/80 even if \< 95th percentile) / Possibly related to the research.
Frequency: 1 affected / 9 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Grade 1 (Mild unsteadiness or sensation of movement) / Possibly related to the research.
Frequency: 1 affected / 9 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Notes: Grade 1 (Asymptomatic, intervention not indicated) / Possibly related to the research.
Frequency: 2 affected / 9 at risk

Adverse event: Retinal vascular disorder
Serious: no
Organ System: Eye disorders
Notes: Grade 2 (Retinal Microaneurysm of Left Eye; Retinal vascular disorder without neovascularization) / Not related to the study
Frequency: 1 affected / 9 at risk

Adverse event: Nervous System Disorders - Other, specify
Serious: no
Organ System: Nervous system disorders
Notes: Grade 2 (Carpal Tunnel Syndrome; Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL) / Not Related to study
Frequency: 1 affected / 9 at risk

Adverse event: Retinopathy
Serious: no
Organ System: Eye disorders
Notes: Grade 2 (Symptomatic; moderate decrease in visual acuity (best corrected visual acuity 20/40 and better or 3 lines or less decreased vision from known baseline); limiting instrumental ADL) / Not related to study
Frequency: 1 affected / 9 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Grade 2 (Moderate depressive symptoms; limiting instrumental ADL) / Not related to study
Frequency: 1 affected / 9 at risk