Anticancer Drug-induced Cardiac Adverse Events in Metastatic Colorectal Cancer: Insights From the French County Calvados Registry
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Difference in rates of cardiovascular adverse events leading to hospitalization between chemotherapy treated patients and chemotherapy-free patients.
研究概览
简要总结
This study is a retrospective observational study that evaluates the rate of cardiovascular adverse events leading to hospitalization in metastatic colorectal cancer in the French county Calvados by drug exposure.
详细描述
This study investigates the characteristics of cardiovascular adverse events leading to hospitalization in metastatic colorectal cancer. Descriptive analysis will include incidence, type of cardiovascular adverse events.
We will explore the incidence of cardiovascular adverse events with regard of the antineoplastic drug exposures. This will provide information about the individual drug safety profiles.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a metastatic colorectal cancer diagnosed between 2004 and 2014 in the French county Calvados
排除标准
- •Minors < 18 year old
- •Patients without a metastatic colorectal cancer diagnosed between 2004 and 2014 in the French county Calvados
研究组 & 干预措施
Metastatic colorectal cancer
The French county Calvados registry of digestive cancers will allow to identify patients with a metastatic colorectal cancer diagnosed between 2004 and 2014.
Patients will be included if the cancer was diagnosed at the metastatic stage between 2004 and 2014 or non-metastatic before 2004 that became metastatic between 2004 and 2014 (synchronous and metachronous tumors)
干预措施: Antineoplastic Agents (Drug)
结局指标
主要结局
Difference in rates of cardiovascular adverse events leading to hospitalization between chemotherapy treated patients and chemotherapy-free patients.
时间窗: Between 2004 and 2017
Any cardiovascular adverse event (e.g. the non limitative list: ischaemic heart disease, heart failure, hypertension, ischaemic stroke, embolic or thrombotic events, arrhythmias, conductive disorders) that was the primary diagnosis of a hospital admission. Any anticancer drug (chemotherapy) intake will be considered for the primary analysis. We will use a competing risk statistical model.
次要结局
- Risk of cardiovascular adverse events (any) for each individual anticancer drug.(Between 2004 and 2017)
- Risk of cardiovascular adverse events (any) for each anticancer drugs combination/protocol(Between 2004 and 2017)
- Dose-effect relation ship between individual anticancer drugs and cardiovascular adverse events(Between 2004 and 2017)
- Dose-effect relation ship between individual anticancer drugs combination/protocol and cardiovascular adverse events(Between 2004 and 2017)
- Risk of individual cardiovascular adverse events of chemotherapy treated patients versus chemotherapy-free patients(Between 2004 and 2017)