Monitoring the Neurological Toxicity of Enzalumatide Through VigiBase, a Pharmacovigilance Study
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
- Number of patients with neurological adverse events with significant over-reporting enzalutamide
研究概览
简要总结
Enzalutamide may lead to various adverse reactions. This study investigates reports of different neurological toxicities in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).
详细描述
Enzalutamide are responsible of a wide range of side effects.The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of adverse drug reactions following treatment with enzalutamide
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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 the World Health Organization (WHO) database of individual safety case reports to 01/01/2020 Adverse events reported were including any MedDRA terms Patients treated with enzalutamide reported in the WHO database.
排除标准
- •Chronology not compatible between the drug and the toxicity
研究组 & 干预措施
Enzalutamide drug-induced toxicity
Cases reported in the World Health Organization (WHO) and the French pharmacovigilance database of patients treated by enzalutamide, with a chronology compatible with the drug toxicity
干预措施: Enzalutamide (Drug)
结局指标
主要结局
Number of patients with neurological adverse events with significant over-reporting enzalutamide
时间窗: Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020
Identification and report of neurological toxiciy of enzalutamdie
次要结局
未报告次要终点
研究者
Joe Elie Salem
Principal Investigator
Groupe Hospitalier Pitie-Salpetriere