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Evaluation of time to onset and outcome of cardiac adverse events associated with nilotinib using post-marketing surveillance
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  • Yuko Kanbayashi,
  • Asuka Kojima,
  • Haruka Wakabayashi,
  • Tadashi Shimizu,
  • Mayako Uchida
Yuko Kanbayashi
Osaka Ika Yakka Daigaku

Corresponding Author:[email protected]

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Asuka Kojima
Doshisha Joshi Daigaku
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Haruka Wakabayashi
Doshisha Joshi Daigaku
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Tadashi Shimizu
Hyogo Ika Daigaku
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Mayako Uchida
Doshisha Joshi Daigaku
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Abstract

Purpose: The present study aimed to evaluate the risk of nilotinib-induced cardiac adverse events (CAEs), time to onset, incidence rates, and post hoc outcomes using the Japanese Adverse Drug Event Report database. Methods: We analysed data for the period between April 2004 and March 2022. Data on CAEs were extracted and relative risk of adverse events (AEs) was estimated using the reporting odds ratio (ROR). Results: We analysed 2,021,907 reports and identified 3,545 reports of AEs caused by nilotinib. Of these, 511 reports involved CAEs. Signals were detected for 19 CAEs. Of these, electrocardiogram QT prolonged was the most frequently reported (30.9%). Fatal outcomes were observed in eight AEs: cardiac failure, atrial fibrillation, acute myocardial infarction, pericardial effusion, myocardial infarction, cardiac arrest, pericarditis, and cardiac tamponade. Of these, acute myocardial infarction, myocardial infarction, pericarditis, and cardiac tamponade exhibited mortality rates >10%. A histogram of median times to onset showed nilotinib-associated AEs occurring 3–485 days after nilotinib administration. Conclusions: We focused on CAEs caused by nilotinib as post-marketing AEs. Some cases resulted in serious outcomes. Patients should be monitored for signs of onset of these AEs not only at the start of administration, but for a long period of time.