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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 study consisting of 10 patients, five patients (three men and two women) aged 21-52 years were described, who developed cytomegalovirus (CMV) reactivation, Escherichia coli urinary tract infection (UTI), oral HSV1 infection, coronavirus influenza, graft-versus-host disease (GVHD) or Enterococcus UTI following treatment with alemtuzumab, antithymocyte globulin [rabbit antithymocyte globulin], cyclophosphamide, fludarabine, mycophenolate mofetil or sirolimus as conditioning regimen for haploidentical haematopoietic stem cell transplantation (HSCT) or GVHD prophylaxis [routes, duration of treatments to reaction onsets and outcomes not stated for all].
Patient B from table 1 of the article: A 52-year-old man developed CMV reactivation following treatment with alemtuzumab and...
- Saraf SL, et al. Haploidentical Peripheral Blood Stem Cell Transplantation Demonstrates Stable Engraftment in Adults with Sickle Cell Disease. Biology of Blood and Marrow Transplantation 24: 1759-1765, No. 8, Aug 2018. Available from: URL: http://doi.org/10.1016/j.bbmt.2018.03.031 - USACrossRefPubMedGoogle Scholar