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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 51-year-old woman experienced lack of efficacy during treatment with prednisone for acute severe ulcerative pan-colitis. Additionally, she experienced lack of efficacy during treatment with methylprednisolone and prednisone for post-colectomy enteritis.
The woman presented with diarrhoea containing mucus and blood at the age of 51 years and she was diagnosed with acute severe ulcerative pan-colitis. She received treatment with prednisone; however, her severe ulcerative pan-colitis was refractory to prednisone. Additionally, the ulcerative pan-colitis complicated by Cytomegalovirus (CMV) infection. She was diagnosed with backwash ileitis at the age of 49 years. As severe ulcerative pan-colitis was refractory to prednisone, she underwent sub-total colectomy and ileostomy in...
- Yang Y, et al. A literature review and case report of severe and refractory post-colectomy enteritis. BMC Gastroenterology 19: 61, No. 1, 25 Apr 2019. Available from: URL: http://doi.org/10.1186/s12876-019-0974-4 - China