Identification of PAthways of Kinase Inhibitors TOxicity Through Patient Databases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Comparison of the incidence of kinase inhibitor (KIs) induced toxicities in health records and their associations with co-medications to identify new mechanisms of drug induced toxicity
研究概览
简要总结
The investigators are identifying clinical diagnoses and toxicities associated with kinase inhibitors prescription. This identification will be applied will be applied in an electronic-health-record (EHR) cohort including North American and European.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient treated with a kinase inhibitor
- •Patient identified in the VUMC EHR cohort or having a toxicity reported in the VigiBase
排除标准
- 未提供
研究组 & 干预措施
VUMC EHR cohort
De-identified version of the electronic health record (EHR) at Vanderbilt University Medical Center (VUMC).
干预措施: Kinase inhibitor (Drug)
Toxicity induced by kinase inhibitors in Vigibase database
Case reported in the World Health Organization (WHO) of toxicity or complication of patient treated by KIs, with a chronology compatible with the drug toxicity
干预措施: Kinase inhibitor (Drug)
结局指标
主要结局
Comparison of the incidence of kinase inhibitor (KIs) induced toxicities in health records and their associations with co-medications to identify new mechanisms of drug induced toxicity
时间窗: population included in VUMC database and/or WHO's database resource up to march 2019
Identification of a mechanism of a toxicity associated with a KI using comedications and comparing it to reported outcomes
次要结局
未报告次要终点
研究者
Joe Elie Salem
Investigator
Groupe Hospitalier Pitie-Salpetriere