Author Information
An event is serious (based on the ICH definition) when the patient outcome is:
* death
* life-threatening
* hospitalisation
* disability
* congenital anomaly
* other medically important event
In a retrospective case-noncase study, conducted as pharmacovigilance analysis of 5532 ICSRs from VigiBase, a 68-year-old man from Australia 1 was described, who developed kidney disorder following treatment with remdesivir for COVID-19 [route, dosage, time to reaction onset and outcome not stated].
Footnotes
1
Identifiable patient's demographic details such as age, sex, and country was obtained from direct communication with the author.
Reference
- Chouchana L, et al. Kidney disorders as serious adverse drug reactions of remdesivir in coronavirus disease 2019: a retrospective case-noncase study. Kidney International 99: 1235-1236, No. 5, May 2021. Available from: URL: 10.1016/j.kint.2021.02.015 [DOI] [PMC free article] [PubMed]