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Adherence was measured by Medication Event Monitoring System (MEMS), pill count, and Medication Adherence Report Scale (MARS-5). Nilotinib <jats:italic>C<\/jats:italic><jats:sub>min<\/jats:sub> and patient-reported outcomes (i.e., quality of life, side effects, beliefs, satisfaction) were measured at baseline, 3, 6, and 12 months.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Results<\/jats:title>\n<jats:p>Sixty-eight patients (57.5 \u00b1 15.0 years, 49% female) participated. Median adherence to nilotinib (MEMS and pill count) was \u2265 99% and adherence &lt; 90% was rare. Self-reported nonadherence (MARS-5) increased in the first year of treatment to a third of patients. In line with the strong beliefs in the necessity of taking nilotinib, forgetting to take a dose was more prevalent than intentionally adjusting\/skipping doses. Nilotinib <jats:italic>C<\/jats:italic><jats:sub>min<\/jats:sub> were generally above the therapeutic target in 95% of patients. Patients reported a variety of side effects, of which fatigue was most frequent. The mean <jats:italic>C<\/jats:italic><jats:sub>min<\/jats:sub> was higher in patients who reported severe itching and fatigue. The overall 1-year MMR rate ranged from 47 to 71%.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Conclusion<\/jats:title>\n<jats:p>Substantial nonadherence (&lt; 90%) to nilotinib was rare and nilotinib <jats:italic>C<\/jats:italic><jats:sub>min<\/jats:sub> were generally above the therapeutic target. Lack of response in our group of patients was not related to nonadherence or inadequate <jats:italic>C<\/jats:italic><jats:sub>min<\/jats:sub>. Nevertheless, a considerable number of patients experienced difficulties in adhering to the twice daily fasted dosing regimen, emphasizing the importance of continuous support of medication adherence in CML.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Clinical trial registration<\/jats:title>\n<jats:p>NTR3992 (Netherlands Trial Register, <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.trialregister.nl\">www.trialregister.nl<\/jats:ext-link>)<\/jats:p>\n<\/jats:sec>","DOI":"10.1007\/s00228-020-02910-3","type":"journal-article","created":{"date-parts":[[2020,6,2]],"date-time":"2020-06-02T22:02:51Z","timestamp":1591135371000},"page":"1213-1226","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Response and Adherence to Nilotinib in Daily practice (RAND study): an in-depth observational study of chronic myeloid leukemia patients treated with nilotinib"],"prefix":"10.1007","volume":"76","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0202-3612","authenticated-orcid":false,"given":"Christel C. 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The other authors declare no conflict of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}