Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology
Standard
Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology. / Spencer, Rebecca N; Hecher, Kurt; Norman, Gill; Marsal, Karel; Deprest, Jan; Flake, Alan; Figueras, Francesc; Lees, Christoph; Thornton, Steve; Beach, Kathleen; Powell, Marcy; Crispi, Fatima; Diemert, Anke; Marlow, Neil; Peebles, Donald M; Westgren, Magnus; Gardiner, Helena; Gratacos, Eduard; Brodszki, Jana; Batista, Albert; Turier, Helen; Patel, Mehali; Power, Beverley; Power, James; Yaz, Gillian; David, Anna L.
In: PRENATAL DIAG, Vol. 42, No. 1, 01.2022, p. 15-26.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology
AU - Spencer, Rebecca N
AU - Hecher, Kurt
AU - Norman, Gill
AU - Marsal, Karel
AU - Deprest, Jan
AU - Flake, Alan
AU - Figueras, Francesc
AU - Lees, Christoph
AU - Thornton, Steve
AU - Beach, Kathleen
AU - Powell, Marcy
AU - Crispi, Fatima
AU - Diemert, Anke
AU - Marlow, Neil
AU - Peebles, Donald M
AU - Westgren, Magnus
AU - Gardiner, Helena
AU - Gratacos, Eduard
AU - Brodszki, Jana
AU - Batista, Albert
AU - Turier, Helen
AU - Patel, Mehali
AU - Power, Beverley
AU - Power, James
AU - Yaz, Gillian
AU - David, Anna L
N1 - © 2021 The Authors. Prenatal Diagnosis published by John Wiley & Sons Ltd.
PY - 2022/1
Y1 - 2022/1
N2 - OBJECTIVE: Adverse event (AE) monitoring is central to assessing therapeutic safety. The lack of a comprehensive framework to define and grade maternal and fetal AEs in pregnancy trials severely limits understanding risks in pregnant women. We created AE terminology to improve safety monitoring for developing pregnancy drugs, devices and interventions.METHOD: Existing severity grading for pregnant AEs and definitions/indicators of 'severe' and 'life-threatening' conditions relevant to maternal and fetal clinical trials were identified through a literature search. An international multidisciplinary group identified and filled gaps in definitions and severity grading using Medical Dictionary for Regulatory Activities (MedDRA) terms and severity grading criteria based on Common Terminology Criteria for Adverse Event (CTCAE) generic structure. The draft criteria underwent two rounds of a modified Delphi process with international fetal therapy, obstetric, neonatal, industry experts, patients and patient representatives.RESULTS: Fetal AEs were defined as being diagnosable in utero with potential to harm the fetus, and were integrated into MedDRA. AE severity was graded independently for the pregnant woman and her fetus. Maternal (n = 12) and fetal (n = 19) AE definitions and severity grading criteria were developed and ratified by consensus.CONCLUSIONS: This Maternal and Fetal AE Terminology version 1.0 allows systematic consistent AE assessment in pregnancy trials to improve safety.
AB - OBJECTIVE: Adverse event (AE) monitoring is central to assessing therapeutic safety. The lack of a comprehensive framework to define and grade maternal and fetal AEs in pregnancy trials severely limits understanding risks in pregnant women. We created AE terminology to improve safety monitoring for developing pregnancy drugs, devices and interventions.METHOD: Existing severity grading for pregnant AEs and definitions/indicators of 'severe' and 'life-threatening' conditions relevant to maternal and fetal clinical trials were identified through a literature search. An international multidisciplinary group identified and filled gaps in definitions and severity grading using Medical Dictionary for Regulatory Activities (MedDRA) terms and severity grading criteria based on Common Terminology Criteria for Adverse Event (CTCAE) generic structure. The draft criteria underwent two rounds of a modified Delphi process with international fetal therapy, obstetric, neonatal, industry experts, patients and patient representatives.RESULTS: Fetal AEs were defined as being diagnosable in utero with potential to harm the fetus, and were integrated into MedDRA. AE severity was graded independently for the pregnant woman and her fetus. Maternal (n = 12) and fetal (n = 19) AE definitions and severity grading criteria were developed and ratified by consensus.CONCLUSIONS: This Maternal and Fetal AE Terminology version 1.0 allows systematic consistent AE assessment in pregnancy trials to improve safety.
U2 - 10.1002/pd.6047
DO - 10.1002/pd.6047
M3 - SCORING: Journal article
C2 - 34550624
VL - 42
SP - 15
EP - 26
JO - PRENATAL DIAG
JF - PRENATAL DIAG
SN - 0197-3851
IS - 1
ER -