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Article History

Received: 9 August 2024

Accepted: 22 November 2024

First Online: 23 December 2024

Declarations

:

: Ako Matsuo-Ohsawa and Jun Katada are full-time employees of Pfizer Japan Inc., which is a co-promotion partner with Bristol-Myers Squibb Co., for the marketing of apixaban.

: The study was conducted in accordance with the Japanese Ethical Guidelines for Medical and Health Research Involving Human Subjects and with the Declaration of Helsinki’s ethical principles for medical research involving human subjects, including research on identifiable human material and data. This study used data existing in an anonymized structured format in the MDV database and not containing any patient personal information, which, according to applicable international and local legal requirements, are not subject to privacy laws. According to the “Ethical Guidelines for Human Life Science and Medical Research” in Japan, informed consent is not required for studies using unlinkable anonymized data. Therefore, obtaining written informed consent from patients or approval from the institutional review board or an independent ethics committee was not required. The MDV database is a commercially available database, and we have access to it under contract with MDV Co. Inc. In addition, as this study was not aimed at evaluating the effectiveness or safety of a specific drug and corresponds to an epidemiological study or a survey of actual medical conditions, it is not registered in any clinical trial registry, such as ClinicalTrials.gov.