Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology
(2022) In Prenatal Diagnosis 42(1). p.15-26- Abstract
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... (More)
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.
(Less)
- author
- organization
- publishing date
- 2022
- type
- Contribution to journal
- publication status
- published
- subject
- in
- Prenatal Diagnosis
- volume
- 42
- issue
- 1
- pages
- 15 - 26
- publisher
- John Wiley & Sons Inc.
- external identifiers
-
- pmid:34550624
- scopus:85116898973
- ISSN
- 0197-3851
- DOI
- 10.1002/pd.6047
- language
- English
- LU publication?
- yes
- additional info
- Publisher Copyright: © 2021 The Authors. Prenatal Diagnosis published by John Wiley & Sons Ltd.
- id
- fbfaaebb-facd-49ac-af0d-9eed90f02707
- date added to LUP
- 2021-11-16 09:36:57
- date last changed
- 2024-04-20 15:23:16
@article{fbfaaebb-facd-49ac-af0d-9eed90f02707,
abstract = {{<p>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.</p>}},
author = {{Spencer, Rebecca N. and Hecher, Kurt and Norman, Gill and Marsal, Karel and Deprest, Jan and Flake, Alan and Figueras, Francesc and Lees, Christoph and Thornton, Steve and Beach, Kathleen and Powell, Marcy and Crispi, Fatima and Diemert, Anke and Marlow, Neil and Peebles, Donald M. and Westgren, Magnus and Gardiner, Helena and Gratacos, Eduard and Brodszki, Jana and Batista, Albert and Turier, Helen and Patel, Mehali and Power, Beverley and Power, James and Yaz, Gillian and David, Anna L.}},
issn = {{0197-3851}},
language = {{eng}},
number = {{1}},
pages = {{15--26}},
publisher = {{John Wiley & Sons Inc.}},
series = {{Prenatal Diagnosis}},
title = {{Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology}},
url = {{http://dx.doi.org/10.1002/pd.6047}},
doi = {{10.1002/pd.6047}},
volume = {{42}},
year = {{2022}},
}