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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a case series, two boys aged 13-year-old were described, who developed caecum perforations and pseudomembranous toxicities following immunosuppressive therapy with mycophenolate mofetil [routes and durations of treatments to reactions onsets not stated].
Case 1: The 13-year-old boy was hospitalised due to ongoing abdominal pain and diarrhoea that lasted for 3−4 weeks. On anamnesis, it was revealed that, he had undergone an allogeneic HSCT three months prior to the current admission, for his underlying acute lymphoblastic leukaemia. Thereafter, he reported a persistent sharp abdominal pain localised at the right lower quadrant, with watery diarrhoea (without blood) that occurred 6−7 times a day. His ongoing medications included mycophenolate mofetil [Cellcept] 2*600 µg/m2 [sic...
- Karagun BS, et al. Cecum perforation induced by mycophenolate mofetil after hematopoietic stem cell transplantation: A case report and review of literature. Pediatric Transplantation 22: No. 6, Sep 2018. Available from: URL: http://doi.org/10.1111/petr.13223 - Turkey