Chimeric Antigen Receptor T-cell and Cellular Therapies for the Treatment of cAncer or BLood Diseases: Evaluation of Reporting of Adverse Events
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100,000
- 试验地点
- 1
- 主要终点
- Number of patients with adverse events with significant over-reporting CAR-T cells and other cellular therapies
研究概览
简要总结
CAR-T cells and cellular therapies may lead to various adverse reactions. This study investigates reports of different toxicities for cellular therapies in the World Health Organization's (WHO) global database of individual safety case reports (VigiBase).
详细描述
CAR-T cells and cellular therapies 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 cellular therapies
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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 to 01/01/2020
- •Adverse events reported were including any MedDRA terms
- •Patients treated with cellular therapies 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
Adverse Events with cellular therapies
Cases reported in the World Health Organization (WHO) and the French pharmacovigilance database of patients treated by Chimeric Antigen Receptor T-cell and Cellular Therapies, with a chronology compatible with the drug toxicity
干预措施: CAR T-cell and Cellular Therapies (Drug)
结局指标
主要结局
Number of patients with adverse events with significant over-reporting CAR-T cells and other cellular therapies
时间窗: Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020
Identification and report of various toxicities of cellular therapies.
次要结局
- Description of the type of adverse event depending on the class and the target of cellular therapy(Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020)
- 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 2020)
- 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 2020)
- Description of the pathologies (cancer) for which the incriminated drugs have been prescribed(Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020)
- Description of the population of patients having an adverse event(Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020)
- Description of the duration of treatment when the toxicity happens and the time to onset(Case reported in the World Health Organization (WHO) of individual safety case reports to January 2020)
研究者
Joe Elie Salem
Principal Investigator
Groupe Hospitalier Pitie-Salpetriere