Pharmacovigilance Assessment of Reporting of Cardiovascular Adverse Events With Antineoplastic Agents (PARCA)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 800,000
- 主要终点
- Cardio-vascular toxicity of antineoplastic agents
研究概览
简要总结
The aim of this observational study is to explore and analyze reports of cardiac or vascular adverse events linked to the administration of antineoplastic agents among patients diagnosed with tumors represented by advanced non-small cell lung cancer. The study leverages pharmacovigilance databases such as the World Health Organization (WHO) database (VigiBase), FDA Adverse Event Reporting System (FAERS), and others to gather individual safety case reports for analysis.
详细描述
Concomitant antineoplastic drug therapy may produce serious adverse cardiac or vascular system events. In this study, reports of cardiovascular adverse drug events following treatment with antineoplastic drugs were investigated using the World Health Organization (WHO) personal safety case report database (VigiBase) and FDA Adverse Event Reporting System (FAERS).
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/
- •Adverse events reported were including the MedDRA terms: Cardiac disorders (SOC), Vascular disorders (SOC), Cardiac and vascular investigations (excl enzyme tests) (HLGT), Sudden death (PT), Sudden cardiac death (PT), Cardiac arrhythmias (HLGT), Cardiac disorder signs and symptoms (HLGT), Cardiac neoplasms (HLGT), Cardiac valve disorders (HLGT), Coronary artery disorders (HLGT), Endocardial disorders (HLGT), Heart failures (HLGT), Myocardial disorders (HLGT), Pericardial disorders (HLGT), Vascular disorders NEC(HLGT), Vascular inflammations(HLGT), Embolism and thrombosis(HLGT), Vascular hypertensive disorders(HLGT), Blood pressure disorders NEC(HLGT), Venous varices(HLGT), Arteriosclerosis, stenosis, vascular insufficiency and necrosis(HLGT), Aneurysms and artery dissections(HLGT).
- •Patients treated with antineoplastic agents (including small-molecule kinase inhibitors, immune checkpoint inhibitors, monoclonal antibodies, cytotoxic drugs, and other therapeutics).
- •The number of reports corresponding to each drug or adverse event is at least three.
- •The primary indication is malignant tumors, specifically advanced non-small cell lung cancer.
排除标准
- •Any of the information in the baseline information such as gender, age, region, date of report is empty.
- •The severity level of the reported adverse event is empty.
- •Adverse events were reported in patients whose drug indications included cardiovascular disease.
研究组 & 干预措施
Adverse Events with Antineoplastic agents
Cases reported in VigiBase, FAERS and other pharmacovigilance databases of patients treated by antineoplastic agents, with a chronology compatible with the drug toxicity.
干预措施: Antineoplastic Agents (Drug)
结局指标
主要结局
Cardio-vascular toxicity of antineoplastic agents
时间窗: Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024
Identification and report of the cardio-vascular toxicity of antineoplastic agents. The research includes the report with MedDRA terms: SOC Cardiac Disorders, SOC Vascular Disorders, Cardiac and vascular investigations (excl enzyme tests) (HLGT), Skeletal and cardiac muscle analyses (HLT), Sudden death (PT). Drugs investigated are antineoplastic agents.
次要结局
- Assess cardiovascular toxicity differences among antineoplastic agent classes and within the same class.(Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024)
- Assessment of the severity of cardiovascular toxicity associated with antineoplastic agents(Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024)
- Description of the duration of treatment when the toxicity happens (role of cumulative dose)(Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024)
- Description of the drug-drug interactions associated with adverse events.(Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024)
- Causality assessment of reported cardiovascular events according to pharmacovigilance databases(Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024)
- Assessment of the association between cardiovascular toxicity due to antineoplastic agents and risk factors.(Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024)
- Description of the population of patients having a cardio-vascular adverse events(Case reported in VigiBase, FAERS and other pharmacovigilance databases of individual safety case reports to 12/31/2024)