Background: Serious adverse reactions and events (SAREs) are a threat to the safety and outcome of transplantation. World Health Assembly Resolution WHA 63.22 urges Member States to collaborate in collecting and share data on SARE. The global experience to date has not been reviewed and is not readily available to clinicians globally.
Methods: Project Notify was a joint initiative co-sponsored by WHO, CNT and the EU supported Project Vigilance and Surveillance of Substances of Human Origin (SOHO V&S). Standard definitions of SAREs were utilized. Published reports of SAREs of the substances under consideration were collected and analyzed. The database has been curated by editorial groups and have begun making parts available online (www.notifylibrary.org).
Results: More than 116 experts from over 36 countries reviewed ∼1,700 references. Typical alerting symptoms, latency (when available) and means of establishing imputability are included. To date there have been 193 infectious, 135 malignancy, 65 living donor, 33 process related and 23 genetic SARs included in the database and an additional 79 SAEs. This represents about 50% of the cases reviewed thus far. 236 (45%) of these events and reactions are related to solid organ transplants. Additional data review will likely increase the overall number of identified SAEs and SARs for inclusion.
Conclusions: This represents the first attempt to organize the global experience of SAREs in a single, publically searchable database. The Notify Library website promises to serve clinicians, regulators, potential donors and patients who wish to understand better the risks associated with donation or human application as well as professionals who need information when deciding on the suitability of a potential donor.
To cite this abstract in AMA style:Ison M, Strong D, Fehily D, Chatzixiros E, Costa A, Noel L. Project NOTIFY: A Global Database of Serious Adverse Events and Reactions in Organs, Tissues, and Cells [abstract]. Am J Transplant. 2013; 13 (suppl 5). https://atcmeetingabstracts.com/abstract/project-notify-a-global-database-of-serious-adverse-events-and-reactions-in-organs-tissues-and-cells/. Accessed October 28, 2020.
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