Monitoring Drug-induced Myocarditis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- Number of myocarditis induced by drugs and report of cases of myocarditis associated with drugs.
研究概览
简要总结
Several drugs and chemotherapies seem to induce myocarditis. This study investigates reports of myocarditis, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).
详细描述
Several drugs and chemotherapies seem to have an impact on the myocardium and are responsible of myocarditis. Those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. This study investigates the main characteristics of patients affected by myocarditis side effect imputed to drugs. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.
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 WHO's pharmacovigilance database till 25/02/2019
排除标准
- •Chronology not compatible between the drug and the toxicity
研究组 & 干预措施
myocarditis induced by drugs and chemotherapies
Case reported in the World Health Organization (WHO) of myocarditis of patient treated by a drug, with a chronology compatible with the drug toxicity
干预措施: Drug inducing myocarditis (Drug)
结局指标
主要结局
Number of myocarditis induced by drugs and report of cases of myocarditis associated with drugs.
时间窗: Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019
次要结局
- Causality assessment of reported myocarditis events according to the WHO system(Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019)
- Description of the myocarditis depending on the category of drug(Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019)
- Description of the other related adverse events concomitant to the myocarditis induced by drugs(Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019)
- 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 25/02/2019)
- 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 25/02/2019)
- Description of the population of patients having myocarditis adverse event(Case reported in the World Health Organization (WHO) database of individual safety case reports to 25/02/2019)
- 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 25/02/2019)
研究者
Joe Elie Salem
Assistant director, clinical investigation center Paris Est
Groupe Hospitalier Pitie-Salpetriere