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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 retrospective study involving 10 patients (cases presented between 1995 and 2016) described four patients [one woman and three men aged 66−81 years] residing in USA, who developed oropharyngeal histoplasmosis during immunosuppression with prednisone, methotrexate, rituximab, fludarabine, bendamustine, etanercept or infliximab [routes, dosages and duration of treatments to reactions onsets not stated].
Case 1 (Patient 4): A 79-year-old woman, who had rheumatoid arthritis, was receiving immunosuppressive therapy with prednisone and methotrexate. She presented in 2009 with throat pain for 6 months and tongue pain/odynophagia for 9 months. She was found to have developed oropharyngeal histoplasmosis localised at epiglottis and tongue (positive cultures and fungal organisms on...
- Pincelli T, et al. Oropharyngeal histoplasmosis: a report of 10 cases. Clinical and Experimental Dermatology 44: e181-e188, No. 5, Jul 2019. Available from: URL: http://doi.org/10.1111/ced.13927 - USA