Hepatotoxicity Related to Protein Kinase Inhibitors in Cancer Patients : an Observational and Retrospective Study Using the FDA Adverse Event Reporting System (FAERS)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600,000
- 试验地点
- 1
- 主要终点
- Hepatotoxicities cases reports related to PKIs (from FAERS database).
研究概览
简要总结
Although protein kinase inhibitors (PKIs) have proved effective in treating many cancers, few patients receiving PKIs may experience rare but life-threatening hepatotoxicity such as hepatic failure. Today, there is no large-scale retrospective pharmacovigilance study focusing on protein kinase inhibitors-related hepatotoxicity.
The objective was to investigate reports of hepatotoxicity related to protein kinase inhibitors using FDA Adverse Event Reporting System (FAERS).
详细描述
The investigators plan to include FDA approved PKIs from PKIDB, a curated, annotated and updated database of protein kinase inhibitors (https://www.icoa.fr/pkidb/).
The search terms of hepatotoxicities will be extracted from "Drug related hepatic disorders-comprehensive search (SMQ)" in MedDRA (Medical Dictionary for Regulatory Activities).
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Case reported in the FAERS database of individual safety case reports at the time of the extraction,
- •Patients treated with at least 1 PKIs.
排除标准
- •Chronology not compatible between the PKIs and hepatotoxicities
结局指标
主要结局
Hepatotoxicities cases reports related to PKIs (from FAERS database).
时间窗: From 2004 to Sep, 2021
The investigators plan to identify number of cases of hepatotoxicities (especially severe toxicities such as hepatic failure) reports related to PKIs reported in the FAERS database by using reporting odds ratios (ROR) and information component (IC), two common method in disproportionality analysis. Clinical features such as gender, age and indications will be displayed, too.
次要结局
- Description of the time to onset of hepatotoxicities after PKIs exposure.(From 2004 to Sep, 2021)
- Description of the fatality cases.(From 2004 to Sep, 2021)
研究者
Miao Yan, PhD
Associate Professor
Central South University