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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 29-year-old woman developed abdominal discomfort and mucousy diarrhoea following treatment with azithromycin for pharyngitis and Clostridium difficile infection (CDI) during treatment with ciprofloxacin, clindamycin, fluconazole and rifaximin [dosages not stated; not all routes, durations of treatments to reactions onsets and outcomes stated].
The woman had a history of severe irritable bowel syndrome with diarrhoea (IBS-D) and anxiety disorder. In July 2015, she presented with severe haemorrhoidal bleeding secondary to IBS and underwent anal sphincterotomy and haemorrhoidectomy in August 2015. A week prior to the surgery, she developed pharyngitis and received treatment with azithromycin. However, the treatment with azithromycin resulted in abdominal discomfort and mucousy...
- Hitschfeld M, et al. The role of a sequencing-based clinical intestinal screening test in patients at high-risk for Clostridium difficile and other pathogens: A case report. Journal of Medical Case Reports 13: 15 Jan 2019. Available from: URL: http://doi.org/10.1186/s13256-018-1919-1 - USA