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Article History

Received: 12 January 2024

Accepted: 19 August 2025

First Online: 2 October 2025

Declarations

:

: The ethics committee of the Medical Faculty of Bonn waved the need for approval since this is not required retrospective analyses based on pseudonymized spontaneous reports and stated that there are no ethical concerns (file no. 458/20 and 100/21). For this study, informed consent to participate was not applicable. No surveys or examinations were carried out on patients. The analyzed data is routinely collected, and stored in the adverse drug reaction database EudraVigilance from the European Medicines Agency (EMA). Among others, pharmaceutical companies, physicians, pharmacists and patients report these ADRs (information concerning the reporting channels see Dubrall et al., 2018 (25)). Further information concerning the processing of personal data in the context of the operation of EudraVigilance Human can be found in the European Medicines Agency’s Data Protection Notice for EudraVigilance Human (- human-ev_en.pdf). The Federal Institute for Drugs and Medical Devices (BfArM) as a national competent authority is granted with the highest level of access to EudraVigilance since one of the core duties of the BfArM is to analyze EudraVigilance data in order to fulfill its pharmacovigilance obligations.

: Not applicable.

: 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.