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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 71-year-old woman developed toxic epidermal necrolysis syndrome (TEN), acute kidney injury, acute tubular necrosis, ileus, sepsis, diarrhoea, melena, hypotension, intra-abdominal abscess caused by Klebsiella oxytoca and Acinetobacter baumanii, bowel perforation, oesophagitis, gastric ulcers and mucosal ulcerations during treatment with allopurinol [route and dosage not stated].
The woman, who had a history of gout, presented to the hospital with a 7 day history of fever, rash and acute kidney injury. Two weeks before the presentation, she started receiving allopurinol for gout prophylaxis. At outside hospital, she had a punch biopsy of her skin confirming TEN and was started on prednisone and methylprednisolone at outside hospital.
On presentation, the woman received treatment...