Data Source
In this retrospective case-non-case study, we used VigiBase, the World
Health Organization (WHO) global database of individual case safety
reports developed and maintained by Uppsala Monitoring Centre. VigiBase
is the largest pharmacovigilance database globally, with over 30 million
reports of ADR from 140 countries
(https://who-umc.org/vigibase),
and contains data on the region of origin, patient (age group and sex),
ADR, onset/end date, seriousness, and outcome), and medication data
(indication, start/end dates, dose, regimen, and route of
administration). WHODrug and MedDRA were used to code the recorded drugs
and the adverse effects in this study, respectively. We received
institutional review board exempt due to public availability of the
database.