NCT05602103尚未招募不适用
Identification of Anticancer Drugs Associated With Cancer Therapy-related Cardiac Dysfunction Reporting in Pediatrics - Analysis of the WHO Pharmacovigilance Database
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10,000
- 主要终点
- cancer therapy-related cardiac dysfunction associated with anticancer drugs
研究概览
简要总结
Little is known about cancer therapy-related cardiac dysfunction occuring in children treated by anticancer drugs for malignancies. Here the investigators use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, to identify and describe cases of cancer therapy-related cardiac dysfunction associated with anticancer drugs.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase)
- •related to children
- •and reported, or not, cancer therapy-related cardiac dysfunction
排除标准
- •cases reported in the World Health Organization (WHO) database of individual safety case reports (vigibase) related to adult patients
结局指标
主要结局
cancer therapy-related cardiac dysfunction associated with anticancer drugs
时间窗: from inception to the April 31, 2024
identification and description of cases of cancer therapy-related cardiac dysfunction associated with anticancer drugs in the World Health Organization (WHO) database of individual safety case reports (vigibase)
次要结局
- Association between cancer therapy-related cardiac dysfunction and anticancer drug exposure in the World Health Organization (WHO) database of individual safety case reports (vigibase)(from inception to the April 31, 2024)
- Description of the malignancies for which the incriminated drugs have been prescribed(from inception to the April 31, 2024)
研究者
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