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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 66-year-old man developed DRESS syndrome complicated by reactivation of Epstein-Barr virus (EBV) and cytomegalovirus (CMV) infection and fatal haemophagocytic lymphohistiocytosis following treatment with allopurinol for gout.
The man, who had a history of gout, presented with spontaneous onset of oedema, excruciating pain and inflammation of the interphalangeal joints of the right hand and the first metacarpophalangeal joint. He was started on treatment with allopurinol 300mg once daily [route not stated] and diclofenac, following which rapid recovery was observed. Two weeks later, he returned to the general practitioner with complaints of erythematous maculopapular rash on his chest and arms followed by malaise, odynophagia and low grade fever.
The man was treated with...