Cardiovascular and Torsades de Pointes Monitoring for Pazopanib
Postmarketing Cardiovascular Ischemia and Torsades de Pointes Monitoring for Pazopanib Using Observational Databases
This observational study is conducted as part of a systematic pharmacovigilance activity, to provide a population-based context for Pazopanib use outside of the clinical trial setting. The aims of the study are to examine the incidence of cardiovascular ischemia (including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident) and cardiac arrhythmia (Torsades de Pointes) in renal cell carcinoma patients treated with marketed anti-VEGF agents [Pazopanib (VOTRIENT), Bevacizumab (AVASTIN), Sorafenib (NEXAVAR), and Sunitinib (SUTENT)].
Two databases will be utilized for this study: a large healthcare claims database in the U.S. and the Dutch linked medical registries (PHARMO RLS). The databases will provide large, geographically varied, non-trial populations in which to examine the incidence of the stated cardiovascular ischemic events and Torsades des Pointes.
研究概览
研究类型
注册 (实际的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
The anti-VEGF cohorts will include patients with the following characteristics:
- Adult patients (age ≥18 years)
- Prescribed or administered an anti-VEGF agent: Pazopanib, Bevacizumab, Sorafenib or Sunitinib on or after approval date of Pazopanib
- Diagnosed with renal cell cancer
Exclusion Criteria:
- Patients with multiple primary cancer diagnoses
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Subjects who experience cardiac ischemia
Subjects who experience cardiac ischemia including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident
|
Patients treated with pazopanib
Patients treated with other anti-VEGFs including Bevacizumab, Sorafenib, and Sunitinib
|
|
Subjects who do not experience cardiac ischemia
|
Patients treated with pazopanib
Patients treated with other anti-VEGFs including Bevacizumab, Sorafenib, and Sunitinib
|
|
Subjects who experience Torsades de Pointes
|
Patients treated with pazopanib
Patients treated with other anti-VEGFs including Bevacizumab, Sorafenib, and Sunitinib
|
|
Subjects who do not experience Torsades de Pointes
|
Patients treated with pazopanib
Patients treated with other anti-VEGFs including Bevacizumab, Sorafenib, and Sunitinib
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cardiovascular ischemia
大体时间:Over four years from approval of pazopanib
|
Cardiovascular ischemia including myocardial infarction, unstable angina, transient ischemic attack, and cerebrovascular accident
|
Over four years from approval of pazopanib
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Torsades de Pointes
大体时间:Over four years from approval of pazopanib
|
Torsades de Pointes
|
Over four years from approval of pazopanib
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.