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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 of 231 patients, three men and two women aged 43−67 years old were described who developed cytomegalovirus (CMV) colitis following treatment with dasatinib, cytarabine, mitoxantrone or etoposide [routes and durations of treatments to reactions onsets not stated, not all dosages stated].
Patient 1:The 67-year-old man had a history of CML and received dasatinib 100 mg/day for 14 months prior to presentation. He presented with a three day history of diarrhoea. Physical examination revealed mild abdominal pain without any tenderness. At hospitalisation, his laboratory findings were a WBC count of 19 430 /mm3, haemoglobin 8.0 g/dL, platelet count of 239 000 /mm3and a blood urea nitrogen/creatinine ratio of 85.2/3.08 mg/dL. On the second day, his WBC count sharply...
- Choi J-K, et al. Cytomegalovirus colitis during dasatinib treatment for patients with Hematologic Malignancy: Case series and literature review. Infection and Chemotherapy 50: 153-159, No. 2, Jun 2018. Available from: URL: https://doi.org/10.3947/ic.2018.50.2.153 - South KoreaCrossRefPubMedGoogle Scholar