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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac complication induced by VEGF/VEGFR inhibitor | Drug | Case reported in the World Health Organization (WHO) of cardiac complication of patient treated by AAs, with a chronology compatible with the drug toxicity |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with an AA for a cancer
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM. | Paris | 75013 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29698683 | Background | 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. | |
| 28916378 | Background | 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. |
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| 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 |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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