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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 woman in her 30's [specific age at the time of reaction onset not stated] developed extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma) during treatment with prednisone and tacrolimus [routes and time to reaction onset not stated].
In 2015, the woman reported for a surveillance colonoscopy. Her medical history included an autoimmune hepatitis treated with a liver transplant in 1997, prolonged iron deficiency anaemia and ulcerative colitis diagnosed in 2004. Her daily medications included prednisone 5mg/day and tacrolimus 5mg twice a day for anti-rejection immunosuppression, which coincidentally also controlled her ulcerative colitis. The surveillance colonoscopy was performed, which revealed mild erythema and friability in the rectum....