Data sources and applied methods for paclitaxel safety signal discernment

Data sources and applied methods for paclitaxel safety signal discernment

BackgroundFollowing the identification of a late mortality signal, the Food and Drug Administration (FDA) convened an advisory panel that concluded that additional clinical study data are needed to comprehensively evaluate the late mortality signal observed with the use of drug-coated balloons (DCB)...

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Bibliographic Details
Main Authors: Laura Elisabeth Gressler, Erika Avila-Tang, Jialin Mao, Alejandra Avalos-Pacheco, Fadia T. Shaya, Yelizaveta Torosyan, Alexander Liebeskind, Madris Kinard, Christina D. Mack, Sharon-Lise Normand, Mary E. Ritchey, Danica Marinac-Dabic
Format: Article
Language:English
Published: Frontiers Media S.A. 2024-02-01
Series:Frontiers in Cardiovascular Medicine
Subjects:
paclitaxel-coated devices
stents
balloons
data quality
signal discernment
latemortality
Online Access:https://www.frontiersin.org/articles/10.3389/fcvm.2023.1331142/full

Internet

https://www.frontiersin.org/articles/10.3389/fcvm.2023.1331142/full

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