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

Vascular Diseases Clinical Trial

— VEGAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03413176
• Other study ID #: CIC1421-18-02
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: January 31, 2018

Study information

• Verified date: September 2019
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150000
• Est. completion date: January 31, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Complication
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
France	AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

References & Publications (2)

Alexandre J, Moslehi JJ, Bersell KR, Funck-Brentano C, Roden DM, Salem JE. Anticancer drug-induced cardiac rhythm disorders: Current knowledge and basic underlying mechanisms. Pharmacol Ther. 2018 Sep;189:89-103. doi: 10.1016/j.pharmthera.2018.04.009. Epub 2018 Apr 24. Review. — View Citation

Gougis P, Wassermann J, Spano JP, Keynan N, Funck-Brentano C, Salem JE. Clinical pharmacology of anti-angiogenic drugs in oncology. Crit Rev Oncol Hematol. 2017 Nov;119:75-93. doi: 10.1016/j.critrevonc.2017.08.010. Epub 2017 Sep 1. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardio-vascular toxicity of AAs	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.	Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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