Evaluation of Reporting of Immune Checkpoint Inhibitor Associated Cardio-vascular 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
- 104
- 试验地点
- 1
- 主要终点
- Cardio-vascular toxicity of ICIs.
研究概览
简要总结
Immune checkpoint inhibitors (ICIs) might have high grade immune-related adverse events (irAEs) on the cardio-vascular system. This study investigates reports of cardio-vascular toxicity with treatment including anti-PD1, Anti-PDL-1, and Anti CTLA4 classes using the World Health Organization (WHO) database VigiBase.
详细描述
ICIs have dramatically improved clinical outcomes in multiple cancer types and are increasingly being tested in earlier disease settings and used in combination. However, irAEs 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 ICIs.
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 12/31/2017
- •Adverse event 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 ICIs included in the ATC: Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32).
排除标准
- •Chronology not compatible between the drug and the toxicity
研究组 & 干预措施
Myocarditis induced by Immune check point inhibitor
Case reported in the World Health Organization (WHO) of myocarditis of patient treated by ICI, with a chronology compatible with the drug toxicity
干预措施: ICI (Drug)
结局指标
主要结局
Cardio-vascular toxicity of ICIs.
时间窗: Case reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2017
Identification and report of the cardio-vascular toxicity of ICIs. 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). Drugs investigated are ICIs: Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32).
次要结局
- 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 12/31/2017)
- 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 12/31/2017)
- 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 12/31/2017)
- 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 12/31/2017)
- Description of the type of cardiotoxicity depending on the category of ICIs(Case reported in the World Health Organization (WHO) database of individual safety case reports to 12/31/2017)
- 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 12/31/2017)
研究者
Joe Elie Salem
Principle investigator
Groupe Hospitalier Pitie-Salpetriere