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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiac Complication, Vascular Diseases

Intervention / Treatment
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* Drug: Cardiac complication induced by VEGF/VEGFR inhibitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VEGFR, VEGF, antiangiogenics, angiogenesis