Gauffin, Oskar http://orcid.org/0000-0003-1593-356X
Brand, Judith S. http://orcid.org/0000-0002-3720-1274
Vidlin, Sara Hedfors http://orcid.org/0000-0003-1619-3751
Sartori, Daniele http://orcid.org/0000-0003-3634-0317
Asikainen, Suvi
Català, Martí
Chalabi, Etir
Dedman, Daniel
Danilovic, Ana
Duarte-Salles, Talita
García Morales, Maria Teresa
Hiltunen, Saara
Jödicke, Annika M.
Lazarevic, Milan
Mayer, Miguel A.
Miladinovic, Jelena
Mitchell, Joseph
Pistillo, Andrea
Ramírez-Anguita, Juan Manuel
Reyes, Carlen
Rudolph, Annette
Sandberg, Lovisa
Savage, Ruth
Schuemie, Martijn
Spasic, Dimitrije
Trinh, Nhung T. H.
Veljkovic, Nevena
Vujovic, Ankica
de Wilde, Marcel
Zekarias, Alem
Rijnbeek, Peter
Ryan, Patrick
Prieto-Alhambra, Daniel
Norén, G. Niklas http://orcid.org/0000-0002-4595-230X
Funding for this research was provided by:
Innovative Medicines Initiative (No 806968)
Article History
Accepted: 17 September 2023
First Online: 7 October 2023
Declarations
:
: This activity under the European Health Data & Evidence Network (EHDEN) has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 806968. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA.
: Suvi Asikainen and Saara Hiltunen are employed by BCB Medical Oy; Martijn Schuemie and Patrick Ryan are employed by Johnson & Johnson. All other authors have no conflict of interest to declare.
: The data from VigiBase that support the findings of this study are not publicly available due to the agreements that govern the WHO Programme for International Drug Monitoring but subsets thereof are available upon reasonable request. Analyses of routinely collected health data were performed locally, these data are not available through a public repository and cannot be shared without approval from data custodians due to ethical and legal restrictions.
: The use of CPRD Aurum and CPRD GOLD data was approved by the CPRD Research Data Governance Process (Protocol 22_002077); the use of SIDIAP data was approved by the Scientific Committee and Ethical Research Committee (CEI, Comité de Ética de Investigación<i>;</i> 22/181-P<i>)</i> of IDIAPJGol; the use of NHR data was approved by the Regional Committee for Research Ethics (155294/REK Nord) and the Data Protection Officer at the University of Oslo (523275); the use of H12O data was approved by the Ethical Committee of the Hospital Universitario 12 de Octubre (22/385); the use of IPCI data was approved by the IPCI Review Board (approval number 3/2019); the use of IMASIS data was approved by the of the Parc Salut Mar Clinical Research Ethics Committee (2022/10535); the use of UCCS data was approved by the Ethics Committee of the UCCS (340); the use of CHCZ data was approved by the CHC Zvezdara Ethics Board (20-01-2023); the use of UCCNis data was approved by the UCC Nis clinical research ethical committee (121521/497).
: Not applicable.
: Not applicable.
: The code used for characterizing the routine health data for this study is publicly available in ATLAS (ExternalRef removed).
: OG, JSB, SHV, DS, PeR, PaR, DPA and GNN were responsible for the conceptualization of this work. MC, EC, DD, AD, MTGM, AMJ, ML, MAM, JM, AP, JMRA, CR, DS, NTHT, NV, AV and MW were responsible for data curation and formal analysis of the routine health data. All authors were involved in interpreting the results from the data. OG, JSB, SHV, DS and GNN drafted the manuscript. All authors reviewed and edited the manuscript and approved the final version for submission.