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

Groupe Hospitalier Pitie-Salpetriere

Status: Completed

Conditions: Cardiac Complication; Vascular Diseases

Treatments: Drug: Cardiac complication induced by VEGF/VEGFR inhibitor

Study type: Observational

Funder types: Other

Identifiers

NCT03413176

CIC1421-18-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018
• Adverse event reported were including the MedDRA terms: Cardiac disorders (SOC), Vascular disorders (SOC), Sudden death (PT)
• Patients treated with antiangiogenics included in the following list:

Exclusion criteria

• Chronology not compatible between the drug and the toxicity