Pancytopenia Related to PARP Inhibitors in Cancer Patients : an Observational and Retrospective Study Using the WHO's Pharmacovigilance Database (PancytoRIB)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Pancytopenia reports related to PARPi.
研究概览
简要总结
Although PARP inhibitors (PARPi) have proved effective in treating many cancers, few patients receiving PARPi may experience rare but serious adverse events such as pancytopenia. Today, data about pancytopenia are scarce.
The objective was to investigate reports of pancytopenia adverse events related to PARPi, including olaparib, rucaparib, niraparib, talazoparib, veliparib and pamiparib using the World Health Organization's (WHO) pharmacovigilance database: VigiBase.
详细描述
Here, investigators use the World Health Organization's (WHO) database of individual safety case reports, to identify cases of pancytopenia related to PARPi.
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 World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction,
- •patients treated with at least 1 PARPi (with ATC classification system): olaparib (ATC L01XX46), niraparib (ATC L01XX54), rucaparib (ATC L01XX55), talazoparib (ATC L01XX60), veliparib (none) and pamiparib (none).
排除标准
- •chronology not compatible between the PARPi and adverse event.
结局指标
主要结局
Pancytopenia reports related to PARPi.
时间窗: From inception to Feb, 2021
Identification of the pancytopenia adverse event related to PARP inhibitors reported in the World Health Organization's (WHO) database of individual safety case reports.
次要结局
- Description of the latency period since first PARPi exposure.(From inception to Feb, 2021)
- Description of patients who experienced co-reported adverse events(From inception to Feb, 2021)
- Description of the fatality rate.(From inception to Feb, 2021)