Evaluation of the feasibility of conducting a non-interventional post-authorisation safety study (NI-PASS) of outcomes associated with the use of tacrolimus before conception or during pregnancy using real-world data

This feasibility project aims to assess the potential of selected data sources in providing adequate sample size to conduct a potential safety study evaluating pregnancy outcomes after exposure to tacrolimus and alternative immunosuppressants. The objectives are to estimate the count of pregnancies in which the mother or father is a transplant recipient exposed to tacrolimus or alternative immunosuppressants, to describe transplantation types among the pregnancies and timing of maternal exposure