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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 a retrospective, observational, real-life study of 100 patients, five women [exact ages at reaction onsets not stated] were described, who developed rebound of multiple sclerosis (MS) after discontinuation of fingolimod therapy for MS [dosages, routes and outcomes not stated].
Patient 1: A woman was diagnosed with MS at the age of 20 years. Five years after MS diagnosis, she started receiving treatment with fingolimod for relapsing-remitting MS. Thereafter, her fingolimod therapy was discontinued due to the desire of pregnancy. Expanded Disability Status Scale (EDSS) was 2 at the time of fingolimod discontinuation. Two months after fingolimod discontinuation, her lymphocytes count was 1200 /µL. Brain MRI findings revealed T2 lesions and Gd+ lesions. EDSS at the of...