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Article History

Received: 5 March 2026

Accepted: 4 August 2026

First Online: 11 September 2026

Declarations

Conflict of interest: Shuichi Hironaka has received consulting fees from Astellas and BeOne Medicines (formerly BeiGene); and has received honoraria from Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Chugai Pharmaceutical Co., Ltd, Daichii Sankyo, Eli Lilly, Merck Biopharma, MSD, Novartis, Ono Pharmaceutical Co., Ltd., Servier, Taiho Pharmaceutical Co., Ltd, and Takeda Pharmaceutical. Yuya Kimijima, Yorifumi Kikko, and Tsunehisa Yamamoto are employees of Bristol Myers Squibb. Yusuke Shinno, Eiji Nishiyama, and Yuko Matsuda are employees of Ono Pharmaceutical Co., Ltd. Bruno Casaes Teixeira is an employee of and holds stock or stock options in Bristol Myers Squibb. Takaki Yoshikawa has received honoraria from Astellas, AstraZeneca, Bristol-Myers Squibb, Chugai Pharmaceutical Co., Ltd, Daiichi Sankyo, Intuitive Surgical, Johnson & Johnson, Medtronic, Olympus, Ono Pharmaceutical Co., Ltd., and Taiho Pharmaceutical; has received research funding from Eli Lilly; and has acted in a consulting or advisory role for MSD and Terumo Corporation. Tsunehisa Yamamoto’s affiliation has changed since the completion of the manuscript. The current affiliation is now Heartseed Inc., Tokyo, Japan.

Ethical Approval: The study was conducted in accordance with International Society for Pharmacoepidemiology (ISPE) Guidelines for Good Pharmacoepidemiology Practices (GPP) and applicable regulatory requirements. Institutional review board approval was not required because the Medical Data Vision (MDV) data sources have undergone extensive ethical review and approval, and the database is compliant with regulations associated with scientific and medical research involving human subjects, including the use of patient-level data, in Japan. Informed consent from patients was also not required because data elements in the MDV database have been de-identified. Data were processed as anonymized information, with personal identifiers masked. The use and analysis of data from the database is considered to be secondary use of the data and is compliant with the Act on the Protection of Personal Information (available here: ). The MDV database used in this study was accessed and used under a data license/use agreement with MDV Co., Ltd. (Tokyo, Japan).