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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, eight patients (three men and five women) aged 71−84 years were described, who developed myelosuppression, infection, nausea and vomiting, abnormal liver function or lack of efficacy while receiving chemotherapy with decitabine, omacetaxine-mepesuccinate, mitoxantrone, etoposide, cytarabine or aclarubicin between September 2009 and March 2012 for acute myeloid leukaemia [AML; not all dosages and routes stated; times to reactions onsets not stated].
Patient 1: A 75-year-old woman, who had AML, started receiving IV infusion (IV gtt) of decitabine [DAC; 5-aza-2'-deoxycytidine] 20 mg/m2over one hour, once daily, from day 1−5 of a 4-week cycle. She received twelve such cycles. This was followed by 2 cycles of IV decitabine in combination with omacetaxine-mepesuccinate...
- Zhou HW, et al. Clinical Efficacy of Decitabine Combined with or without Cytarabine-based Low Dose Regimen for Senile patients with Acute Myeloid Leukemia Zhongguo Shi Yan Xue Ye Xue Za Zhi 26: 91-96, No. 1, Feb 2018. Available from: URL: http://doi.org/10.7534/j.issn.1009-2137.2018.01.015 [Chinese; summarised from a translation] - ChinaGoogle Scholar