Evaluation of Reporting of AdVerse Events Associated With AnTicAncer theRapy : an Observational and Retrospective Study Using the WHO Pharmacovigilance Database(AVATAR)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000,000
- 试验地点
- 1
- 主要终点
- Adverse events of antineoplastic and immunomodulating agents
研究概览
简要总结
Anticancer drugs can lead to various adverse events. This study analyses reports of adverse events for treatment including Anatomical Therapeutic Chemical (ATC) classification L (antineoplastic agents, endocrine therapy, immunostimulants, and immunosuppressants drugs) in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).
详细描述
The investigators use VigiBase, the World Health Organization (WHO) database of individual safety case reports, to identify cases of adverse events following treatment with antineoplastic agents, endocrine therapy, immunostimulants or immunosuppressants drugs.
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
- — 至 100 Years（Child, 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 at the time of the extraction
- •Adverse events reported were including in the MedDRA terms. The research could include the report with SOC, HGLT, HLT, or PT MedDRA terms
- •Patients treated with Antineoplastic and immunomodulating agents included in the ATC L.
排除标准
- •Chronology not compatible between the drug and the toxicity
研究组 & 干预措施
Adverse Events associated with Antineoplastic and Immunomodulating Agents
Cases reported in the World Health Organization (WHO) and the French pharmacovigilance database of patients treated by anticancer drugs, with a chronology compatible with the drug toxicity
干预措施: Antineoplastic and Immunomodulating Agents (Drug)
结局指标
主要结局
Adverse events of antineoplastic and immunomodulating agents
时间窗: Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025
Identification and report of adverse event of antineoplastic and immunomodulating agents. The research could include the report with SOC, HGLT, HLT, or PT MedDRA terms
次要结局
- Description of the cancer for which the incriminated drugs have been prescribed(Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025)
- Causality assessment of reported adverse events according to the WHO system(Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025)
- Description of the type of adverse event depending on the category of antineoplastic and immunomodulating agents(Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025)
- Description of the time from anticancer drug initiation and the occurrence of the adverse event(Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025)
- Description of the drug-drug interactions associated with adverse events(Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025)
- Description of the population of patients having adverse event(Case reported in the World Health Organization (WHO) of individual safety case reports to January 1st 2025)