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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In an observational case series study comprising of patients followed between January 2016 and December 2018, four patients (three women and one man) aged 24-55 years were described who developed hepatitis E virus (HEV) infection during treatment with fingolimod or dimethyl fumarate for multiple sclerosis (MS).
Patient 1: A 24-year-old woman developed HEV infection during treatment with fingolimod for MS. The woman, who had relapsing-remitting MS, was receiving treatment with glatiramer acetate. Subsequently, she was switched to oral fingolimod [dosage not stated]. However, 10 months after initiation of fingolimod therapy, laboratory investigation revealed asymptomatic elevation of liver enzymes. Serological examination demonstrated positive serology for HEV with IgM 2.1 and...