Ketoconazole (all routes except local only)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Molgaard-Nielsen, 2013	Denmark 1996 - 2011	All liveborn infants who were born in Denmark during the study period.	Women who fill prescriptions for oral ketoconazole agents during the first trimester.	unexposed (general population or NOS) Women who did not fill prescriptions for oral azole antifungal agents during the first trimester.	72 / 968236	Oral exposure.

Study	Country Study period	Case	Control	Sample size	Rmk
Carter, 2008	USA 1997 - 2003	Cases with selected birth defects (included live births, stillbirths 20 weeks or longer or greater than 500 g, or elective terminations).	Live births without birth defects that were randomly selected from birth certificates or birth hospitals in the geographic regions monitored by the state surveillance systems.	12274 / 4774
Kazy, 2005	Hungary 1980 - 1996	Cases with isolated and multiple congenital anomalies selected from the Hungarian Congenital Abnormality Registry.	Newborn infants without congenital abnormality.	22843 / 38151	Oral ketoconazole exposure.