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

Sponsor

Groupe Hospitalier Pitie-Salpetriere (Other)

Overall Status

Completed

CT.gov ID

NCT03413176

Collaborator

(none)

150,000

Enrollment

Location

Actual Duration (Days)

152187.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Complication Vascular Diseases	Drug: Cardiac complication induced by VEGF/VEGFR inhibitor

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

150000 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Jan 15, 2018

Actual Study Completion Date :

Jan 31, 2018

Outcome Measures

Primary Outcome Measures

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

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 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 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]
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 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.	Paris		France	75013

Sponsors and Collaborators

Groupe Hospitalier Pitie-Salpetriere

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Joe Elie Salem, MD, Groupe Hospitalier Pitie-Salpetriere

ClinicalTrials.gov Identifier:

NCT03413176

Other Study ID Numbers:

CIC1421-18-02

First Posted:

Jan 29, 2018

Last Update Posted:

Sep 26, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Joe Elie Salem, MD, Groupe Hospitalier Pitie-Salpetriere

Additional relevant MeSH terms:

Vascular Diseases

Study Results

No Results Posted as of Sep 26, 2019