Carcinoma, Renal Cell Clinical Trial
Official title:
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.
n/a
Observational Model: Cohort, Time Perspective: Retrospective
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