Cavadino, Alana http://orcid.org/0000-0002-5709-367X
Sandberg, Lovisa http://orcid.org/0000-0001-6982-5244
Öhman, Inger http://orcid.org/0000-0001-7784-6272
Bergvall, Tomas http://orcid.org/0000-0003-4394-3431
Star, Kristina http://orcid.org/0000-0002-5384-8609
Dolk, Helen
Loane, Maria http://orcid.org/0000-0002-1206-3637
Addor, Marie-Claude
Barisic, Ingeborg
Cavero-Carbonell, Clara
Garne, Ester http://orcid.org/0000-0003-0430-2594
Gatt, Miriam
Khoshnood, Babak
Klungsøyr, Kari http://orcid.org/0000-0003-2482-1690
Latos-Bielenska, Anna
Lelong, Nathalie
Lutke, Reneé
Materna-Kiryluk, Anna
Nelen, Vera
Nevill, Amanda
O’Mahony, Mary
Mokoroa, Olatz
Pierini, Anna
Randrianaivo, Hanitra
Rissmann, Anke http://orcid.org/0000-0002-9437-2790
Tucker, David
Wiesel, Awi
Yevtushok, Lyubov http://orcid.org/0000-0002-3799-7268
Morris, Joan K http://orcid.org/0000-0002-7164-612X
Article History
Accepted: 15 April 2021
First Online: 9 May 2021
Declarations
:
: There was no specific funding for this study. EUROCAT registries are funded as described in “EUROCAT Member Registries: Organization and Processes” [CitationRef removed].
: As of June 2020, Kristina Star is a full-time employee of AstraZeneca. However, all of her contributions to this work were made prior to the time of departure, as part of her employment at Uppsala Monitoring Centre. All other authors declare that they have no conflict of interest.
: Not applicable.
: All data in EUROmediCAT and VigiBase are anonymised; therefore, patient informed consent for this particular study was not required.
: Not applicable.
: EUROmediCAT encourages the use of its data and networks for pharmacovigilance and medication safety research. Individual data are only available to consortium members; however, EUROmediCAT can be commissioned to do a study, or engage in a collaborative study. Requests can be made at http://euromedicat.eu/currentresearchanddata/howtoproposeorcommissionspecificstudies. The VigiBase datasets generated and analysed during the current study are not publicly available due to agreements between contributors of data to the database used (VigiBase) and the custodian of this database. National centres (mainly national drug regulatory authorities) constituting the WHO Programme for International Drug Monitoring (PIDM) contribute data to VigiBase, and UMC is the custodian in its capacity as a WHO collaborating centre for international drug monitoring.
: Not applicable.
: AC: Designed and conceptualised the manuscript; analysed the EUROmediCAT data; interpreted the data; drafted the manuscript; revised the manuscript. LS, IÖ, KS, TB: generated and analysed VigiBase data; interpreted the data: drafted the manuscript; revised the manuscript. HD, ML: Coordinated the dataflow and managed EUROmediCAT registry data; made substantial contributions to the acquisition of data; interpreted the data; revised the manuscript. MA, IB, CC, EG, MG, BK, KK, AL, NL, RL, AM, OM, VN, AN, MO, AP, HR, AR, DT, AW, LY: Managed EUROmediCAT registry data; made substantial contributions to the acquisition of data; revised the manuscript. JKM: Designed and conceptualised the manuscript; supervised the study; interpreted the data; drafted the manuscript; revised the manuscript. All authors read and approved the final version.