Christ, Patrick http://orcid.org/0000-0003-3197-5639
Dubrall, Diana http://orcid.org/0000-0002-8763-051X
Schmid, Matthias http://orcid.org/0000-0002-0788-0317
Sachs, Bernhardt http://orcid.org/0000-0001-8260-0891
Funding for this research was provided by:
Institute for Medical Biometry, Informatics and Epidemiology (IMBIE) at the University Hospital of Bonn (V-2020.2/68502/2020-2024, V-2020.2/68502/2020-2024)
German Federal Institute for Drugs and Medical Devices (V-2020.2/68502/2020-2024, V-2020.2/68502/2020-2024)
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
Article History
Accepted: 20 September 2023
First Online: 21 November 2023
Declarations
:
: Open Access funding enabled and organized by Projekt DEAL. MS and DD were supported by the ANKA project, which is funded by own resources of the German Federal Institute for Drugs and Medical Devices (BfArM) and own resources of the Institute for Medical Biometry, Informatics and Epidemiology (IMBIE) at the University Hospital of Bonn (V-2020.2/68502/2020-2024). The analyses and results presented in this manuscript constitute a subproject within the ANKA project. The open access fee was covered by the Federal Institute for Drugs and Medical Devices (BfArM).
: MS and DD were supported by the ANKA project, which is funded by own resources of the German Federal Institute for Drugs and Medical Devices (BfArM) and own resources of the Institute for Medical Biometry, Informatics and Epidemiology (IMBIE) at the University Hospital of Bonn (V-2020.2/68502/2020-2024). The analyses and results presented in this manuscript constitute a subproject within the ANKA project. The remaining authors have no other conflicts of interest that are directly relevant to the content of this manuscript.
: The pseudonymised ADR reports from EudraVigilance are not publicly accessible due to data protection requirements. Distinct levels of access are provided for various stakeholders (ExternalRef removed). Being one of the competent authorities in Germany, the highest level of access is granted to the Federal Institute for Drugs and Medical Devices (BfArM). Nevertheless, even with the lowest access level, researchers can perform the same analysis in EudraVigilance (EV) with aggregated data (public access: ExternalRef removed). For further information regarding the processing of personal data in the context of the operation of EudraVigilance Human we refer to the European Medicines Agency’s Data Protection Notice for EudraVigilance Human.
: The presented study is a retrospective analysis of pseudonymised reports of adverse drug reactions. According to the local ethics committee of the Medical Faculty of Bonn no ethics approval is needed for this study (file no. 100/21).
: Not applicable.
: Not applicable.
: Not applicable.
: PC, DD and BS contributed to the conception and design of the study. PC performed the data analysis. PC, DD and MS selected the statistical methods. PC, DD and BS performed the evaluation and discussion of the analysis results. PC, DD and BS wrote the first drafts of the manuscript. PC, DD, BS and MS commented on previous versions of the manuscript. All authors read and approved the final manuscript.
: The information and views set out in this manuscript are those of the authors and do not necessarily reflect the official opinion of the Federal Institute for Drugs and Medical Devices.