Bayer, Samuel
Clark, Cheryl
Dang, Oanh
Aberdeen, John http://orcid.org/0000-0002-0112-1037
Brajovic, Sonja
Swank, Kimberley
Hirschman, Lynette
Ball, Robert
Funding for this research was provided by:
U.S. Food and Drug Administration
Article History
Accepted: 2 September 2020
First Online: 2 October 2020
Declarations
: The views in this manuscript are those of the authors and not necessarily those of the US FDA or The MITRE Corporation.
: This work was funded by the US FDA.
: Samuel Bayer, Cheryl Clark, Oanh Dang, John Aberdeen, Sonja Brajovic, Kimberley Swank, Lynette Hirschman, and Robert Ball have no conflicts of interest that are directly relevant to the content of this article.
: Not applicable.
: All participants in ADE Eval provided consent to participate, as well as consent for publication of the results.
: The underlying data for this study are available as structured product labels from ExternalRef removed. Access to the annotated training data and guidelines used in this study for research purposes can be requested through the FDA Technology Transfer Program at techtransfer@fda.hhs.gov.
: Access to the evaluation software used in this study for research purposes can be requested through the FDA Technology Transfer Program at techtransfer@fda.hhs.gov.
: All authors contributed to the design and planning of the annotation and the evaluation. OD, SBr and KS contributed to the annotation effort and the MedDRA<sup>®</sup> coding effort. All authors contributed to the recruitment of participants in the evaluation. SBa, CC, OD, JA, SBr and LH conducted the evaluation. All authors contributed to the manuscript.