Monitoring Drug-induced Uveitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Eye toxicities of drugs Identification and report of cases of uevitis associated with drugs
研究概览
简要总结
Several drugs and chemotherapies seem to induce uveitis. This study investigates reports of uveitis, 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 eyes and are responsible of uveitis. 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 uveitis 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 01/04/2019
排除标准
- •Chronology not compatible between the drug and the toxicity
研究组 & 干预措施
Uveitis induced by drugs and chemotherapies
Case reported in the World Health Organization (WHO) of uveitis of patient treated by a drug, with a chronology compatible with the drug toxicity
干预措施: Drugs inducing uveitis (Drug)
结局指标
主要结局
Eye toxicities of drugs Identification and report of cases of uevitis associated with drugs
时间窗: to 01/04/2019
Case reported in the World Health Organization (WHO) database of individual safety case reports
次要结局
- Causality assessment of reported uveitis according to the WHO system(to 01/04/2019)
- Duration of treatment when uveitis happen (role of cumulative dose)(to 01/04/2019)
- All relevants statisticals associations between type of uveitis and the category of drug(to 01/04/2019)
- All relevants statisticals associations between other concomittants immune related adverse events and uveitis induced by drugs(to 01/04/2019)
- All relevants statisticals associations between drug-drug interactions and adverse events(to 01/04/2019)
- All relevants statisticals associations between pathologies (cancer) for which the incriminated drugs have been prescribed, and occurence of uveitis(to 01/04/2019)
- All relevants statisticals associations between characteristics of the population and occurence of uveitis adverse event(to 01/04/2019)
研究者
Joe Elie Salem
Assistant director, clinical investigation center Paris Est
Groupe Hospitalier Pitie-Salpetriere