European active surveillance study of women taking HRT (EURAS-HRT): study protocol [NCT00214903].

ABSTRACT:

Background

The post marketing safety surveillance program for a drug containing a new chemical entity should assess both, the safety outcomes that relate specifically to the targeted population, as well as those that could potentially be related to special pharmacological characteristics of the drug. Active safety surveillance using valid epidemiological study designs has been proven to be a pertinent and reliable method to approach this endeavor.

Methods/design

The primary objective of the study is to compare incidence rates of serious adverse events in users of all types of newly prescribed oral HRT products. This active surveillance study will assess pertinent cardiovascular outcomes--in particular venous and arterial thromboembolism--and other serious adverse events (SAE

SUBMITTER: Dinger JC 

PROVIDER: S-EPMC1351171 | biostudies-literature | 2006 Jan

REPOSITORIES: biostudies-literature