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Development of stan...
Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology
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- Spencer, Rebecca N. (författare)
- University College London,Leeds School of Medicine
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- Hecher, Kurt (författare)
- University Medical Center Hamburg-Eppendorf
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- Norman, Gill (författare)
- Antenatal Results and Choices Charity,University of Manchester
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- Marsal, Karel (författare)
- Lund University,Lunds universitet,Obstetrik och gynekologi, Lund,Sektion V,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Tornbladinstitutet,Forskargrupper vid Lunds universitet,Obstetrics and Gynaecology (Lund),Section V,Department of Clinical Sciences, Lund,Faculty of Medicine,Tornblad Institute,Lund University Research Groups
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- Deprest, Jan (författare)
- Catholic University of Leuven,University College London
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- Flake, Alan (författare)
- The Children's Hospital of Philadelphia
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- Figueras, Francesc (författare)
- Institutd' Investigacions Biomèdiques August Pi iSunyer (IDIBAPS),University of Barcelona
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- Lees, Christoph (författare)
- Imperial College London
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- Thornton, Steve (författare)
- Queen Mary University
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- Beach, Kathleen (författare)
- GlaxoSmithKline
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- Powell, Marcy (författare)
- GlaxoSmithKline
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- Crispi, Fatima (författare)
- Institutd' Investigacions Biomèdiques August Pi iSunyer (IDIBAPS),University of Barcelona
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- Diemert, Anke (författare)
- University Medical Center Hamburg-Eppendorf
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- Marlow, Neil (författare)
- University College London
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- Peebles, Donald M. (författare)
- University College London Hospital,University College London
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- Westgren, Magnus (författare)
- Karolinska Institute
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- Gardiner, Helena (författare)
- University of Texas Health Science Center at Houston
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- Gratacos, Eduard (författare)
- University of Barcelona
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- Brodszki, Jana (författare)
- Lund University,Lunds universitet,Obstetrik och gynekologi, Lund,Sektion V,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Obstetrics and Gynaecology (Lund),Section V,Department of Clinical Sciences, Lund,Faculty of Medicine
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- Batista, Albert (författare)
- Institutd' Investigacions Biomèdiques August Pi iSunyer (IDIBAPS)
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- Turier, Helen (författare)
- Twins Trust
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- Patel, Mehali (författare)
- Bliss Charity,Sands Charity
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- Power, Beverley (författare)
- The Congenital Diaphragmatic Hernia Support Charity
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- Power, James (författare)
- The Congenital Diaphragmatic Hernia Support Charity
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Yaz, Gillian (författare)
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- David, Anna L. (författare)
- University College London Hospital,University College London
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(creator_code:org_t)
- 2021-10-12
- 2022
- Engelska.
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Ingår i: Prenatal Diagnosis. - : Wiley. - 0197-3851 .- 1097-0223. ; 42:1, s. 15-26
- Relaterad länk:
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http://dx.doi.org/10... (free)
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https://onlinelibrar...
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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http://kipublication...
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Abstract
Ämnesord
Stäng
- 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Reproduktionsmedicin och gynekologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Obstetrics, Gynaecology and Reproductive Medicine (hsv//eng)
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- art (ämneskategori)
- ref (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Spencer, Rebecca ...
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Hecher, Kurt
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Norman, Gill
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Marsal, Karel
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Deprest, Jan
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Flake, Alan
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visa fler...
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Figueras, France ...
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Lees, Christoph
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Thornton, Steve
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Beach, Kathleen
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Powell, Marcy
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Crispi, Fatima
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Diemert, Anke
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Marlow, Neil
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Peebles, Donald ...
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Westgren, Magnus
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Gardiner, Helena
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Gratacos, Eduard
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Brodszki, Jana
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Batista, Albert
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Turier, Helen
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Patel, Mehali
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Power, Beverley
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Power, James
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Yaz, Gillian
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David, Anna L.
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visa färre...
- Om ämnet
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Reproduktionsmed ...
- Artiklar i publikationen
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Prenatal Diagnos ...
- Av lärosätet
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Lunds universitet
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Karolinska Institutet