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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 retrospective single center study involving 45 patients, who received alemtuzumab between 1 January 2003 and 31 October 2014, 11 paediatric patients were described, of whom one was female [specific ages not stated; not all sexes stated] were described, who developed Epstein-Barr virus post-transplant lymphoproliferative disorder (EBV-PTLD; 1 patient), BK virus infection (1 patient), cytomegalovirus (CMV) reactivation (4 patients), disseminated CMV infection (1 patient) and adenovirus infection (4 patients) during conditioning treatment with alemtuzumab [Campath]. Additionally, one patient with BK virus infection developed neutropenia during treatment with ganciclovir for CMV prophylaxis [dosages and routes not stated; not all times to reactions onsets and outcomes stated].
- Cupit-Link MC, et al. EBV-PTLD, adenovirus, and CMV in pediatric allogeneic transplants with alemtuzumab as part of pretransplant conditioning: A retrospective single center study. Journal of Pediatric Hematology/Oncology 40: e473-e478, No. 8, Nov 2018. Available from: URL: http://doi.org/10.1097/MPH.0000000000001138 - USA