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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
A 41-year-old man developed fatal progressive multifocal leukoencephalopathy (PML) and accrued cerebral swelling during treatment with natalizumab, dexamethasone and prednisolone [dosages not stated; not all route stated] for multiple sclerosis. Additionally, he had used dexamethasone and prednisolone without prescription.
The man was diagnosed with multiple sclerosis in May 2006. Subsequently, a pulse therapy with corticosteroids was conducted. In 2012, he was initiated on natalizumab as a participant in the clinical study RusTis. He received 10 infusion of natalizumab during this period. From August 2016 to December 2017, he received 17 infusions. During flair-up, he was prescribed corticosteroid infusions at home. Since 2016, he independently took IM dexamethasone and oral...
- Zakharova MN, et al. [The case-report of progressive multifocal leukoencephalopathy in a patient with multiple sclerosis treated with natalizumab]. [Russian]. Zhurnal Nevrologii i Psikhiatrii Imeni S.S. Korsakova 118: 107-109, No. 8, 2018. Available from: URL: http://doi.org/10.17116/jnevro2018118082107 [Russian; summarised from a translation] - Russia