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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 378 patients treated between 1 January 2012 and 31 December 2016, 43 patients (28 men and 15 women) aged 28−86 years were described, who developed invasive fungal infections (16 patients), invasive bacterial infections (23 patients) or viral infections (4 patients) during treatment with multiple antineoplastics for lymphoid cancers, Waldenstrom macroglobulinaemia (WM) or mycosis fungoides. Six of these 43 patients died due to the infections [routes not stated; not all dosages, durations of treatments to reactions onsets and outcomes stated].
The patients were diagnosed with chronic lymphocytic leukaemia, mantle cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, primary central nervous system lymphoma, WM, mycosis fungoides or marginal zone lymphoma....
- Varughese T, et al. Serious Infections in Patients Receiving Ibrutinib for Treatment of Lymphoid Cancer. Clinical Infectious Diseases 67: 687-692, No. 5, 16 Aug 2018. Available from: URL: http://doi.org/10.1093/cid/ciy175 - USA