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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 cumulative analysis of cases from the manufacturer global company safety and clinical databases, six patients (four women and two men) aged 56−83 years were described, who developed progressive multifocal leukoencephalopathy following treatment with rituximab, azathioprine, cyclophosphamide, denosumab, epirubicin, etanercept, fluorouracil, hydroxychloroquine, infliximab, leflunomide, methotrexate, mycophenolate mofetil, prednisolone, adalimumab, sulfasalazine or unspecified steroids and glucocorticoids for rheumatoid arthritis or granulomatosis with polyangiitis [dosages, duration of treatments to reaction onsets not stated; not all indications, routes and outcomes stated].
A 56-year-old woman developed progressive multifocal leukoencephalopathy following treatment with...