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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, a man in his late 20s [exact age not stated] was described, who developed neutropenia, thrombocytopenia, febrile neutropenia, Staphylococcus epidermidis bacteremia and anaemia following administration of cyclophosphamide as a pre-transplantation conditioning regimen. Additionally, he developed exotropia following administration of tacrolimus for acute graft versus host disease and experienced quick rebound of HIV-infection following interruption of antiretroviral therapy with lamivudine, tenofovir and raltegravir [not all dosages, routes, time to reactions onsets and outcomes stated].
The man was diagnosed with acquired immunodeficiency syndrome (HIV-AIDS) on 14 May 2016 and acute lymphoblastic leukaemia (T-cell type) on 30 May 2016 (i.e. at the age of 27 years). At...
- Xu L, et al. CRISPR-edited stem cells in a patient with HIV and acute lymphocytic leukemia. New England Journal of Medicine 381: 1240-1247, No. 13, 26 Sep 2019. Available from: URL: http://doi.org/10.1056/NEJMoa1817426 - China