Arterial Hypertension With PARP Inhibitors in Cancer Patients: an Observational and Retrospective Study Using the WHO Pharmacovigilance Database (ArteRIB)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,336
- 试验地点
- 1
- 主要终点
- hypertension 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 (or not) adverse events such as hypertension whose data are scarce.
The objective was to investigate reports of hypertension related to PARPi, including olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, and fluzoparib 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 hypertension AE 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, pamiparib, fluzoparib (none).
排除标准
- •chronology not compatible between the PARPi and adverse event
研究组 & 干预措施
parp inhibitors
All patients treated at least with 1 PARPi
干预措施: olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib, fluzoparib (Drug)
结局指标
主要结局
hypertension reports related to PARPi.
时间窗: From inception to 16 Feb, 2023
Identification of the hypertension adverse event related to PARP inhibitors reported in the World Health Organization's (WHO) database of individual safety case reports.
次要结局
未报告次要终点