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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 of 6 patients, 5 patients (3 men and 2 women) [exact ages at the time of reactions onset not stated] were described, who developed pancytopenia, recurrent infectious complications due to prolonged neutropenia, pneumonia, urosepsis with septic shock, neutropenia, febrile neutropenia or thrombopenia following treatment with cladribine, rituximab or pentostatin for hairy cell leukaemia (HCL) [routes, durations of treatments to reactions onsets and outcomes not stated].
Case 1: The woman (aged 68 years at the time of report), was diagnosed with HCL 14 years previously. In November 2002, she received cladribine 0.14 mg/kg/day for 5 days (1 cycle). She developed pancytopenia. A complete response was achieved. However, she had a relapse with 84% hairy cell infiltration...
- Bohn J-P, et al. Low-dose vemurafenib in hairy cell leukemia patients with active infection. American Journal of Hematology 94: E180-E182, No. 6, Jun 2019. Available from: URL: https://doi.org/10.1002/ajh.25474 - Austria