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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
* Drug interaction
A 45-year-old man developed latent tuberculosis (TB) reactivation during treatment with nilotinib for chronic myeloid leukaemia (CML). Additionally, the TB persisted following the interaction between nilotinib and anti-tubercular drugs isoniazid, rifampicin and ethambutol.
The man was diagnosed with chronic phase CML in March 2011. He started receiving imatinib; however, it was stopped in May 2011 as pericardial/pleural effusion and hyperbilirubinaemia were noted [etiology not stated]. Subsequently, imatinib was changed to dasatinib. After one year, he developed grade 3−4 pleural effusion caused by dasatinib. Thrombocytopenia was also seen. On 2 May 2012, dasatinib was switched to nilotinib 400mg twice a day [route not stated]. In December 2014, he presented...
- Kim DJ, et al. First case report of latent tuberculosis reactivation complicating treatment with nilotinib in chronic myeloid leukemia. Blood Research 54: 151-153, No. 2, Jun 2019. Available from: URL: http://doi.org/10.5045/br.2019.54.2.151 - South Korea