Park, Dahyun http://orcid.org/0009-0006-1328-2299
Bea, Sungho http://orcid.org/0000-0003-2622-6553
Bae, Ji-Hwan http://orcid.org/0000-0001-9621-5302
Lee, Hyesung http://orcid.org/0000-0001-6556-9984
Choe, Young June http://orcid.org/0000-0003-2733-0715
Shin, Ju-Young http://orcid.org/0000-0003-1010-7525
Kim, Hoon http://orcid.org/0000-0003-4244-6126
Funding for this research was provided by:
Ministry of Food and Drug Safety (21153MFDS607, 22183MFDS433)
Ministry of Science and ICT, South Korea (NRF-2022M3C1A3092022)
Article History
Accepted: 1 May 2024
First Online: 2 July 2024
Declarations
:
: This work was supported by grants (21153MFDS607 and 22183MFDS433) from the Ministry of Food and Drug Safety of South Korea for the period 2021–2025 and grants (NRF-2022M3C1A3092022) from the Ministry of Science and ICT of South Korea. The funders played no role in the study design, data collection, data analysis, data interpretation, or writing of the manuscript. The corresponding author has full access to all data in the study and has the final responsibility for the decision to submit the manuscript for publication.
: This study was approved by the Institutional Review Board of Sungkyunkwan University (IRB No. SKKU 2023-02-022), which waived the requirement for informed consent because this study used anonymized administrative data.
: The authors declare no conflicts of interest. Hoon Kim has received grants from the Ministry of Science and ICT. Ju-Young Shin has received grants from the Ministry of Food and Drug Safety, the National Research Foundation of Korea, and pharmaceutical companies, including Pfizer, Celltrion, and SK Bioscience. No other relationships or activities influenced the submission of this manuscript.
: Formal consent is not necessary for this retrospective observational pharmacovigilance study.
: Not applicable.
: Data supporting the findings of this study are available from the Uppsala Monitoring Centre; however, restrictions apply to the availability of these data. The data were used under a licence for the current study and are not publicly available. Nevertheless, the data are available from the authors upon reasonable request and with permission from the Uppsala Monitoring Centre.
: Not applicable.
: Dahyun Park designed the study, collected the data, performed statistical analyses, interpreted the data, and wrote the manuscript. Sungho Bea designed the study, interpreted the data, and contributed to the writing of the manuscript. Ji-Hwan Bae and Hyesung Lee interpreted the data and contributed to the statistical analyses. Young June Choe critically interpreted the data and manuscript. Ju-Young Shin designed the study, supervised the statistical analyses and interpretation of the data, accepts full responsibility for the results of this study, has access to the data, and critically revised the manuscript. Hoon Kim, the guarantor of the study, accepts full responsibility for the results of this study, and controls the decision to publish. The corresponding authors attests that all listed authors meet the authorship criteria, and that no others meeting the criteria have been omitted. All authors read and approved the final version.