Sartori, Daniele http://orcid.org/0000-0003-3634-0317
Aronson, Jeffrey K. http://orcid.org/0000-0003-1139-655X
Erlanson, Nils
Norén, G. Niklas http://orcid.org/0000-0002-4595-230X
Onakpoya, Igho J. http://orcid.org/0000-0002-2420-0811
Funding for this research was provided by:
Uppsala Monitoring Centre
Article History
Accepted: 1 February 2024
First Online: 24 February 2024
Declarations
:
: This work is part of Daniele Sartori’s DPhil in Evidence-Based Medicine at the University of Oxford (Nuffield Department of Primary Care Health Sciences and the Department of Continuing Education), UK. The DPhil is fully funded by the UMC.
: J.K.A. has written papers on adverse drug reactions in peer-reviewed journals and has received royalties from textbooks that he has edited or co-edited; he has often acted as an expert witness in cases involving adverse drug reactions, most often in coroners’ courts. D.S. and G.N.N. are employed by the UMC, which manages VigiBase and holds the archives of the signal document used to retrieve part of the included studies. Part of the reviewed materials was published in peer-reviewed journals, drug bulletins and abstracts or posters by researchers presently or formerly belonging to this foundation. Specifically, D.S. has authored signals published on drug bulletins, as abstracts or posters, some of which were included in this review, and received funding for doctoral studies from the UMC. N.E. (formerly UMC) has no competing interests. I.J.O. has no competing interests.
: This research relied on previously collected, anonymised, non-National Health Service data. As such, ethics approval was not required.
: Not applicable.
: Not applicable.
: The data that support the findings of this study are not publicly available. Access to the data is restricted based on the conditions for access within the WHO Programme for International Drug Monitoring. Subject to these conditions, data is available from the authors on reasonable request.
: The code used to retrieve the dates, counts and characteristics of the reports from VigiBase and that used to compute Brunner–Munzel statistics, will be made available on reasonable request.
: D.S. designed the study, with support from I.J.O., J.K.A. N.E. and G.N.N. joined the research team later; the first carried out data retrieval from VigiBase, the other provided essential suggestions for data analysis. This manuscript was written by D.S. with support from I.J.O., N.E., G.N.N. and J.K.A. All authors read and approved the final manuscript.