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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, 4 adult patients [1 woman and 3 men; specific ages not stated] were described, who developed anaemia, neutropenia, thrombocytopenia, febrile neutropenia, Clostridium difficile colitis, acute sinusitis, polycythaemia, pneumonia, sepsis, multiorgan failure, cytomegalovirus reactivation or septic shock during treatment with azacitidine [5-azacytidine], cytarabine, decitabine, sorafenib or venetoclax for acute myeloid leukaemia (AML) [routes not stated, duration of treatments to reaction onsets not stated; not all dosages and outcomes stated].
Case 1: An adult woman in her late 40s, who was diagnosed with refractory AML in August 2016 (at the age of 48 years), underwent haploidentical stem cell transplantation on 18 April 2017 due to relapse. Post-transplant,...
- Moukalled NM, et al. Feasibility of Venetoclax-based combinations for adult patients with acute myeloid leukemia relapsing after allogenic stem cell transplantation. Bone Marrow Transplantation 54: 620-624, No. 4, Apr 2019. Available from: URL: http://doi.org/10.1038/s41409-018-0347-6 - Lebanon