Publications by authors named "Ellen G T Ederveen"

Background: Since the presence of a birth defect is often a primary outcome in drug-safety studies among pregnant women, researching the validity of data collection methods is imperative. The aim of this study is to compare self-reported birth defects in infants by mothers with the information provided by general practitioners (GP (singular) or GPs (plural)).

Methods: Mothers who participated in the Dutch Pregnancy Drug Register reported information about possible birth defects of their infants via questionnaires.

View Article and Find Full Text PDF

After a registered drug is available on the market and used in everyday circumstances, hitherto unknown adverse drug reactions (ADRs) may occur. Furthermore, the patient can experience a previously unknown course of a known ADR. Voluntary reports by patients play an important role in gaining knowledge about ADRs in daily practice.

View Article and Find Full Text PDF