Data sharing
Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda’s Data Sharing Policy (see https://www.takedaclinicaltrials.com/ for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor’s qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Acknowledgments
The authors thank all of the patients who participated in this study. The authors are grateful to the following investigators who participated to this study and provided data; Yoshiki Akatsuka (Fujita Health University School of Medicine, Toyoake), Hideki Asaoku (Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital, Hiroshima), Hideki Goto (Hokkaido University Faculty of Medicine, Graduate School of Medicine, Sapporo), Hitoshi Hanamoto (Kindai University Nara Hospital, Ikoma), Shigeki Ito (Iwate Medical University School of Medicine, Morioka), Manabu Kawakami (Nippon Life Hospital, Osaka), Toshio Kitawaki (Graduate School of Medicine, Kyoto University, Kyoto), Yuichi Mori (Saku Central Hospital, Saku), Akihito Shinohara (Tokyo Women's Medical University, Tokyo), Taizo Shimomura (Kumamoto Shinto General Hospital, Kumamoto), Takayuki Shimizu (Keio University School of Medicine, Tokyo), Jun Taguchi (Shizuoka Red Cross Hospital, Shizuoka), Satoshi Yamamoto (Sapporo City General Hospital, Sapporo), Masahiro Yokoyama (The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo), Toshiyuki Yokoyama (Sendai Medical Center, Sendai), and Kanako Yoshitsugu (Shizuoka Cancer Center, Shizuoka).
Disclosure statement
N. Fukuhara reports grants from Ono Pharmaceutical Co. Ltd., during the conduct of the study. G. Yamamoto reports grants from Takeda Pharmaceutical Co. Ltd., during the conduct of the study; personal fees from Takeda Pharmaceutical Co. Ltd., outside of the submitted work. H. Shibayama reports research funding from Takeda, during the conduct of the study; personal fees from Takeda, Novartis, Celgene, Janssen, Chugai, Eisai, Mundi Pharma, Ono, Otsuka, Kyowa Hakko Kirin, AstraZeneca, Abbvie, Dainippon Sumitomo, Daiichi Sankyo, Fujimoto, Nihon Shinnyaku, Sanofi, and Bristol, outside of the submitted work.
K. Izutsu reports personal fees from Takeda, during the conduct of the study; grants and personal fees from Eisai, MSD, Takeda, Janssen, Mundipharma, Chugai, AstraZeneca, Abbvie, Bayer, Ono, and Celgene; personal fees from Bristol Myers Squib, Dainippon Sumitomo, and Nihon Mediphysics; grants from Gilead, Zenyaku, Solasia, Symbio, Astellas, Amgen, Bayer, and Daiichi Sankyo; and personal fees from Kyowa Hakko Kirin, outside of the submitted work. T. Yanai and K. Shibuya are employees of Takeda Pharmaceutical Co. Ltd. T. Chou and H. Tsujimura report no conflict of interest.