Evaluation of Reporting of VEGF Inhibitors Associated Cardiovasclular Adverse reactioNs Using International Pharmacovigilance Database.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 150,000
- Locations
- 1
- Primary Endpoint
- Cardio-vascular toxicity of AAs
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Cardio-vascular toxicity of AAs
Time Frame: 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 Outcomes
- 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 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 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 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)
Investigators
Joe Elie Salem
MD
Groupe Hospitalier Pitie-Salpetriere