Evaluation of Reporting of VEGF Inhibitors Associated Cardiovasclular Adverse reactioNs Using International Pharmacovigilance Database.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150,000
- 试验地点
- 1
- 主要终点
- Cardio-vascular toxicity of AAs
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
排除标准
- •Chronology not compatible between the drug and the toxicity
结局指标
主要结局
Cardio-vascular toxicity of AAs
时间窗: 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.
次要结局
- 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)
研究者
Joe Elie Salem
MD
Groupe Hospitalier Pitie-Salpetriere