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

Completed

• Conditions: Cardiac Complication; Vascular Diseases

• Registration Number: NCT03413176
• Lead Sponsor: Groupe Hospitalier Pitie-Salpetriere

Brief 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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-01-15
• Study First Submitted: 2018-01-22
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-29
• Study Completion: 2018-01-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardio-vascular toxicity of AAs	Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018	Identification and report of the cardio-vascular toxicity of AAs. The research includes the report with MedDRA terms: SOC Cardiac Disorders, SOC Vascular Disorders, Sudden death (PT). Drugs investigated are: sorafenib, sunitinib, pazopanib, vandetanib, axitinib, regorafenib, nintedanib, lenvatinib, ceritinib, bevacizumab, ramucirumab, aflibercept.

Secondary Outcome Measures

Name	Time	Method
Causality assessment of reported cardiovascular events according to the WHO system	Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018
Description of the population of patients having a cardio-vascular adverse event	Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018
Description of the type of cardiotoxicity depending on the category of AAs	Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018
Description of the drug-drug interactions associated with adverse events	Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018
Description of the pathologies (cancer) for which the incriminated drugs have been prescribed	Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018
Description of the duration of treatment when the toxicity happens (role of cumulative dose)	Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018

Trial Locations

Locations (1)

AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.; 🇫🇷 Paris, France