Azathioprine/prednisolone
Rebound effect in the form of fever, elevation of lactate dehydrogenase, transaminitis, low C3, anti-double stranded DNA positive and lack of efficacy-
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