In:
Prenatal Diagnosis, Wiley, Vol. 42, No. 1 ( 2022-01), p. 15-26
Abstract:
What's already known about this topic? Adverse event (AE) monitoring is central to assessing therapeutic safety. The lack of a comprehensive AE framework in pregnancy trials severely limits understanding risks in pregnant women What does this study add? Through international consensus we systematically developed definitions and severity grading for maternal and foetal AEs: Maternal and Fetal AE Terminology Version 1.0. New fetal AE definitions were adopted by the Medical Dictionary for Regulatory Activities. This terminology should be used to monitor safety in pregnancy trials
Type of Medium:
Online Resource
ISSN:
0197-3851
,
1097-0223
Language:
English
Publisher:
Wiley
Publication Date:
2022
detail.hit.zdb_id:
1491217-X