Global Insights Into Therapeutic Radiopharmaceuticals Safety: A Comprehensive Analysis From the WHO Pharmacovigilance Database (RADIANTS)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500,000
- 试验地点
- 1
- 主要终点
- Toxicity of Radiopharmaceuticals drugs
研究概览
简要总结
Little is known about cancer therapy-related radiopharmaceuticals drugs safety. 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 radiopharmaceuticals drugs.
详细描述
Radiopharmaceuticals drugs especially for therapeutic purposes 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 radiopharmaceuticals 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
- 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)
排除标准
- •not related to radiopharmaceuticals
研究组 & 干预措施
Adverse Events with Radiopharmaceuticals drugs
Cases reported in the World Health Organization (WHO) of patients treated by Radiopharmaceuticals drugs with reported toxicity
干预措施: Radiopharmaceuticals drugs (Drug)
结局指标
主要结局
Toxicity of Radiopharmaceuticals drugs
时间窗: Case reported in the World Health Organization (WHO) of individual safety case reports through study completion, an average 5 years
Identification and report of toxicities of radiopharmaceuticals drugs. The research includes the report with MedDRA terms: System organ class (SOC), Preferred terms (PT), High level group term (HLGT), High level term (HLT)
次要结局
- Individual safety case reports parameters(Through study completion, an average 5 years)