de Filippis, Renato http://orcid.org/0000-0001-6928-1224
Kane, John M. http://orcid.org/0000-0002-2628-9442
Arzenton, Elena http://orcid.org/0000-0002-9778-1522
Moretti, Ugo http://orcid.org/0000-0001-5108-5807
Raschi, Emanuel http://orcid.org/0000-0003-0487-7996
Trifirò, Gianluca
Barbui, Corrado http://orcid.org/0000-0003-1073-9282
De Fazio, Pasquale http://orcid.org/0000-0001-5375-3565
Gastaldon, Chiara http://orcid.org/0000-0001-7257-2962
Schoretsanitis, Georgios http://orcid.org/0000-0002-3851-4117
Funding for this research was provided by:
Università degli studi "Magna Graecia" di Catanzaro
Article History
Accepted: 10 April 2024
First Online: 9 May 2024
Declarations
:
: No commercial organizations had any role in the writing of this paper for publication. In the last 3 years, RdF has received speaker fees from Janssen Pharmaceuticals and Lundbeck and travel support from Lundbeck, Janssen Pharmaceuticals, Otsuka, and ROVI Pharma Industrial Services. JMK has been a consultant and/or advisor for, or has received honoraria from, Alkermes, Allergan, LB Pharmaceuticals, H. Lundbeck, Intracellular Therapies, Janssen Pharmaceuticals, Johnson and Johnson, Merck, Minerva, Neurocrine, Newron, Otsuka, Pierre Fabre, Reviva, Roche, Sumitomo Dainippon, Sunovion, Takeda, Teva, and UpToDate and is a shareholder in LB Pharmaceuticals and Vanguard Research Group. GT participated in advisory boards and seminars on topics not related to this presentation and sponsored by the following pharmaceutical companies in the last 2 years: Eli Lilly, Sanofi, Amgen, Novo Nordisk, Sobi, Gilead, Celgene, and Daikii Sankyo. He is also scientific coordinator of the academic spin-off INSPIRE, which carried out in the last 2 years observational studies/systematic reviews on topics not related to the content of this presentation and which were funded by PTC Pharmaceutics, Kiowa Kirin, Shonogi, Shire, Chiesi, and Daiichi Sankyo. GS has received speaker/consultation fees from Dexcel Pharma, HLS Therapeutics, Saladax, and Thermo Fisher. In the last 3 years, the remaining authors report no conflicts of interest.
: The authors have not declared a specific grant for this research from any funding agency in the public, commercial, or not-for-profit sectors. Open access funding provided by Università degli Studi Magna Graecia di Catanzaro within the CRUI-CARE Agreement.
: All authors formulated the research question and designed the study, carrying it out. EA, UM, and GT extracted the data, based on the search strategy defined by RdF, CG, and GS. RdF, CG, and GS analyzed the data. All authors interpreted the results. RdF wrote the first draft of this article. All authors reviewed, provided modifications, and approved the final version of the study.
: VigiBase® does not allow the distribution of the files with each case of DRESS, but in the tables and in the electronic supplementary material, all detailed information needed to perform the analyses is provided, i.e., number of cases, non-cases, number of other AEs, and total number of reports in VigiBase®. Other requests for data can be submitted to the corresponding UMC. The code will be made available upon reasonable request to the corresponding author.
: The study was conducted in accordance with the principles of the Declaration of Helsinki and approved by the Ethics Committee of University Hospital Mater Domini of Catanzaro (Italy) ‘Regione Calabria, sezione Area Centro’ (n. 103/April 21<sup>st</sup>, 2022). VigiBase®, the WHO global database of individual case safety reports (ICSRs), is the source of the information; the information comes from a variety of sources, and the probability that the suspected adverse effect is drug related is not the same in all cases; the information does not represent the opinion of the UMC or the WHO. According to WHO policy and UMC guidelines, reports sent from the WHO Programme for International Drug Monitoring (PIDM) member countries to VigiBase® are anonymized. Identifiable data are not published.
: Patient consent was waived as VigiBase® database contains anonymized data that cannot allow patients’ identification.
: Not applicable.
: The code will be made available upon reasonable request to the corresponding author.