Evaluation of Reporting of Cardio-vascular Adverse Events With Antineoplastic and Immunomodulating Agents (EROCA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500,000
- 试验地点
- 1
- 主要终点
- Cardio-vascular toxicity of antineoplastic and immunomodulating agents
研究概览
简要总结
Antineoplastic and immunomodulating agents may lead to various cardio-vascular adverse reactions. This study investigates reports of cardio-vascular toxicities for treatment including Anatomical Therapeutic Chemical (ATC) classification L (antineoplastic agents, endocrine therapy, immunostimulants, and immunosuppressants drugs) in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).
详细描述
Antineoplastic therapies are responsible of a wide range of cardio-vascular side effects.The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of cardiovascular adverse drug reactions following treatment with antineoplastic and immunomodulating agents
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
- 0 Years 至 100 Years（Child, 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 30/04/2018
- •Adverse events reported were including the MedDRA terms: Cardiac and vascular investigations (excl enzyme tests) (HLGT), Vascular disorders (SOC), Skeletal and cardiac muscle analyses (HLT), Sudden death (PT), Sudden cardiac death (PT), Cardiac disorders (SOC), Cardiac arrhythmias (HLGT), Cardiac disorder signs and symptoms (HLGT), Cardiac neoplasms (HLGT), Cardiac valve disorders (HLGT), Congenital cardiac disorders (HLGT), Coronary artery disorders (HLGT), Endocardial disorders (HLGT), Heart failures (HLGT), Myocardial disorders (HLGT), Pericardial disorders (HLGT)
- •Patients treated with Antineoplastic and immunomodulating agents included in the ATC L.
排除标准
- •Chronology not compatible between the drug and the toxicity
研究组 & 干预措施
Adverse Events with Antineoplastic and immunomodulating agents
Cases reported in the World Health Organization (WHO) and the French pharmacovigilance database of patients treated by Antineoplastic and immunomodulating agents, with a chronology compatible with the drug toxicity
干预措施: Antineoplastic and Immunomodulating Agents (Drug)
结局指标
主要结局
Cardio-vascular toxicity of antineoplastic and immunomodulating agents
时间窗: Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018
Identification and report of cardio-vascular toxicities of antineoplastic and immunomodulating agents. The research includes the report with MedDRA terms: SOC Cardiac Disorders, SOC Vascular Disorders, Sudden death (PT), Cardiac and vascular investigations (excl enzyme tests) (HLGT), Skeletal and cardiac muscle analyses (HLT)
次要结局
- Description of the drug-drug interactions associated with adverse events(Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018)
- Description of the type of cardiotoxicity depending on the category of antineoplastic and immunomodulating agents(Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018)
- Description of the duration of treatment when the toxicity happens(Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018)
- Description of the pathologies (cancer) for which the incriminated drugs have been prescribed(Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018)
- Description of the population of patients having a cardio-vascular adverse event(Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018)
- Causality assessment of reported cardiovascular events according to the WHO system(Case reported in the World Health Organization (WHO) of individual safety case reports to September 2018)
研究者
Joe Elie Salem
Assistant director, clinical investigation center Paris Est
Groupe Hospitalier Pitie-Salpetriere