Asenapine

Study	Country Study period Study design	Data source	Exposure definition	Non-exposure definition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias

Study	Country Study period Study design	Data source	Case	Control	Exposition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias
Ishikawa 2024	Japan 2005 - 2022 nested case control	The administrative claims database from JMDC Inc. (Tokyo, Japan), which contains all inpatient (including those during hospitalization), outpatient, and pharmacy claims received from the insurers.	Women whose pregnancies ended in a miscarriage that occurred between the beginning of the fourth and 22nd weeks of gestation.	Women randomly selected from the entire cohort of pregnancies by risk-set sampling with replacement and were individu- ally matched to the cases (3:1).	Exposure were identified according to the WHO-ATC or alternate entries in the administrative claims database from JMDC Inc. (Tokyo, Japan), which contains pharmacy claims received from the insurers.	during pregnancy (anytime or not specified)	44118 / 132317
Ishikawa 2024	Japan 2005 - 2022 nested case control		Birth outcomes was unavailable in the Japanese claims database. Pregnancies and birth outcomes were estimated using two methods: the first one was for those whose pregnancy-and birth outcome-related entries were available, and their pregnancies and birth outcomes were estimated using these entries.			during pregnancy (anytime or not specified)	44118 / 132317

Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;