NCT03413176

Evaluation of Reporting of Vascular Endothelial Growth Factor and Vascular Endothelial Growth Factor Receptor Inhibitors Associated Cardiovascular Adverse reactioN.

Evaluation of Reporting of VEGF Inhibitors Associated Cardiovasclular Adverse reactioNs Using International Pharmacovigilance Database.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150,000 (actual)
• Sponsor: Groupe Hospitalier Pitie-Salpetriere · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Antiangiogenics (AAs) which are vascular endothelial growth factor (VEGF) or VEGF receptor (VEGFR) inhibitors might have high grade adverse events (AEs) on the cardio-vascular system. This study investigates reports of cardio-vascular toxicity with treatment including VEGF and VEGFR inhibitors using the World Health Organization (WHO) database VigiBase.

Detailed description

AAs have dramatically improved clinical outcomes in multiple cancer types and are increasingly being tested in earlier disease settings and used in combination. However, AEs can occur. Here the investigators use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, to identify cases of cardiovascular adverse drug reaction following treatment with AAs.

Conditions

• Cardiac Complication
• Vascular Diseases

Interventions

Type	Name	Description
DRUG	Cardiac complication induced by VEGF/VEGFR inhibitor	Case reported in the World Health Organization (WHO) of cardiac complication of patient treated by AAs, with a chronology compatible with the drug toxicity

Timeline

• Start date: 2018-01-01
• Primary completion: 2018-01-15
• Completion: 2018-01-31
• First posted: 2018-01-29
• Last updated: 2019-09-26

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated drug study