Sultiame (Epilepsy = ALL)

Study	Country Study period	Population source	Exposure definition	Non-exposure definition	Sample size	Rmk
Samrén (Sultiame), 1999	Netherlands 1972 - 1994	Offspring of women with epilepsy, with or without antiepileptic drug use during pregnancy, born during the study period.	Children born to mothers with epilepsy and using sultiame monotherapy at least during the first trimester of pregnancy	unexposed, disease free Children born to nonepileptic nonexposed women.	1 / 2000
Tomson (Sulthiame), 2018	42 countries 1999 - 2016	Pregnancies registered in the database during the study period who had been exposed to antiepileptic drug monotherapy and had complete follow-up data up to 1 year. They were enrolled within gestation week 16 and before fetal outcome is known.	Offspring exposed in utero to sulthiame monotherapy during the first trimester and born from epileptic mothers. (This is a subgroup of exposure among the whole exposed group considered in the study).	exposed to other treatment, sick Offspring exposed in utero to lamotrigine monotherapy during the first trimester and born from epileptic mothers.	1 / 2514	This study is an update of Tomson's 2011 publication. They excluded from the current analysis pregnancies occurring in women without epilepsy. EURAP registry: potential overlap.

Study	Country Study period	Case	Control	Sample size	Rmk
Bànhidy (Sultiame), 2011	Hungary 1980 - 1996	Children affected with congenital abnormalities and who had mothers with medically recorded epilepsy.	Newborn infants without congenital abnormality and who had mothers with medically recorded epilepsy.	95 / 90	Malformations caused by major mutant genes or chromosomal aberrations with preconceptional origin were excluded. Exposure period completed with Czeizel 1992. Czeizel 1992 congenital abnormalities results are completely overlapped by this publication.