Dubrall, Diana http://orcid.org/0000-0002-8763-051X
Sachs, Bernhardt http://orcid.org/0000-0001-8260-0891
Kraywinkel, Klaus
Schulz, Maike http://orcid.org/0000-0003-3296-4456
Schmid, Matthias http://orcid.org/0000-0002-0788-0317
Fischer-Barth, Wilma
Bate, Jens http://orcid.org/0000-0003-2843-4196
Article History
Accepted: 16 October 2022
First Online: 19 November 2022
Declarations
:
: The project is funded by the German Federal Institute for Drugs and Medical Devices’ (BfArM) own resources and by the Institute for Medical Biometry, Informatics, and Epidemiology (IMBIE), University Hospital of Bonn, Germany (V-2020.2/68502/2020-2024).
: The authors have no conflicts of interest.
: The study was approved by the local ethics committee of the Medical Faculty of Bonn (file no. 100/21).
: Not applicable.
: Not applicable.
: The data set generated and/or analysed during the current study are not publicly available due data privacy requirements. 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 [CitationRef removed]. Researchers and/or readers who are interested can perform the same analyses in the ADR database EudraVigilance of the European Medicines Agency (EMA) (public access: ExternalRef removed). However, different levels of access are granted for different stakeholders.
: Not applicable.
: BS, DD, WF-B and JB contributed to the study conception and design and performed the causality assessment of the ADR reports. Case identification in the ADR database and data analysis was performed by DD. Statistical analyses were performed by DD and MS. KK provided the data of the cancer registry. The first draft of the manuscript was written by DD and BS. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.