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Article History

Accepted: 3 November 2024

First Online: 21 January 2025

Declarations

:

: ANKA is funded by own resources from the German Federal Institute for Drugs and Medical Devices’ (BfArM) and the Institute for Medical Biometry, Informatics, and Epidemiology (IMBIE), University Hospital Bonn, Germany (V-2020.2/68502/2020-2024). The data provisioning services provided by the data integration center (DIC) Bonn were created with and/or are currently supported, in part, via funding by the Federal Ministry of Education and Science (BMBF) under grant numbers (FKZ): 01ZZ1602C, 01ZZ1803Q, 01ZZ2303G, and 01KX2121.

: DD and MS are supported by the ANKA project, which is founded by the Federal Institute for Drugs and Medical Devices and the Institute for Medical Biometry, Informatics and Epidemiology at the University Hospital Bonn.

: The ethics committee of the Medical Faculty of Bonn waved the need for approval since this is not required for retrospective analyses based on pseudonymized spontaneous reports from EudraVigilance and clinical routine data from the University Hospital Bonn and stated that fthere are no ethical concerns (file no. 458/20 and 100/21). Thus, consent to participate is not required and was not obtained.

: Not applicable.

: Not applicable.

: The pseudonymized ADR reports from EudraVigilance are not publicly accessible due to data protection requirements. Distinct levels of access are provided for various stakeholders (). 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: ). For further information regarding processing 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.

: Not applicable.

: DD, JW, BH, and BS contributed to the conception and design of the study. DD selected the statistical methods, performed the analysis and created all tables and figures. The results were discussed by all authors. The first draft of the manuscript was written by DD. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.