Methotrexate/methylprednisolone/prednisolone
Lack of efficacy, fatal lymphoproliferative disease manifesting in the form of acute diffuse large B cell lymphoma and worsening of acute diffuse large B cell lymphoma : case report-
Serious
An event is determined to be serious (based on the ICH definition) when the patient outcome is:
death
life-threatening
hospitalisation
disability
congenital anomaly
other medically important event