Tofisopam

Exposed non-exposed studies (cohort)

Study Country
Study period
Population source Exposure definition Non-exposure definition Sample size Rmk
Noh, 2022 South Korea
2011 - 2018
All pregnancies in women aged 20 to 45 years at delivery resulting in live births from 1 January 2011 to 31 December 2018, in South Korea. Pregnant women who filled at least Tofisopam prescription during the first trimester (first 90 days of pregnancy). unexposed, sick
Pregnant women who were not prescribed any benzodiazepine from 3 months before the last menstrual period to the end of the first trimester (with similar psychiatric conditions after propensity score).
4804 / 3053381 Propensity scored adjusted for indications and led to an unexposed cohort with similar psychiatric conditions => considered as unexposed, sick control groups.

Case-control studies (cohort)

Study Country
Study period
Case Control Sample size Rmk
Eros, 2002 Hungary
1980 - 1996
Newborn infants with isolated congenital abnormality (CA) and multiple CA. Exclusions of some mild congenital abnormalities and minor congenital abnormality (methods in Czeizel 1999). Two or three newborn infants without congenital anomalies matched to every case according to sex, birth week in the year when the case was born, and district of parents’ residence from the National Birth Registry of the Central Statistical Office. 22865 / 38151

master protocol