Leitzen, Sarah http://orcid.org/0000-0002-1207-4168
Dubrall, Diana http://orcid.org/0000-0002-8763-051X
Toni, Irmgard http://orcid.org/0000-0002-0089-1494
Stingl, Julia http://orcid.org/0000-0002-1566-8156
Christ, Patrick http://orcid.org/0000-0003-3197-5639
Köberle, Ursula http://orcid.org/0000-0001-8537-202X
Schmid, Matthias http://orcid.org/0000-0002-0788-0317
Neubert, Antje http://orcid.org/0000-0001-6575-1452
Sachs, Bernhardt http://orcid.org/0000-0001-8260-0891
Funding for this research was provided by:
Gemeinsame Bundesausschuss (01NVF16021)
German Ministry of Health and German innovation fund of the Federal Joint Committee
Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
Article History
Accepted: 28 September 2022
First Online: 12 November 2022
Declarations
:
: Sarah Leitzen received funding from the KiDSafe project. KiDSafe was funded by the German innovation fund of the Federal Joint Committee (G-BA) under the fund mark 01NVF16021. Antje Neubert received funding from the German Ministry of Health and German innovation fund of the Federal Joint Committee (G-BA).
: Sarah Leitzen, Diana Dubrall, Irmgard Toni, Julia Stingl, Patrick Christ, Ursula Köberle, Matthias Schmid, Antje Neubert, and Bernhardt Sachs have no conflicts of interest to declare.
: Approval for the protocol of the KiDSafe project was obtained from the Ethics Committee of the Friedrich-Alexander University Erlangen-Nürnberg under reference number 351_17 B, and approval for the analysis of the spontaneous reports from EudraVigilance was obtained from the local Ethics Committee of the Medical Faculty of Bonn (009/17 and 100/21).
: Not applicable.
: Not applicable.
: Due to data protection requirements and the EudraVigilance access policy, the individual pseudonymized case reports are not accessible to the readership since different levels of access are granted for different stakeholders [CitationRef removed]. The Federal Institute for Drugs and Medical Devices (BfArM), as the competent authority in Germany, is granted the highest access level; however, even with the lowest level of access researchers can perform the same analyses in EudraVigilance with aggregated data (public access: ExternalRef removed).
: Not applicable.
: Sarah Leitzen, Diana Dubrall and Bernhardt Sachs contributed to the conception and design of the analysis. Irmgard Toni and Antje Neubert contributed to the design of the analysis of the KiDSafe data and provided input to the interpretation and discussion of the data. Patrick Christ and Diana Dubrall contributed to data evaluation. Ursula Köberle gave advice regarding ADR reporting and supervised the recording and assessing within the DCGMA. The first drafts of this manuscript were written by Sarah Leitzen and Bernhardt Sachs. All authors commented on previous versions of the manuscript, and read and approved the final version.