Inoue, Kenichi http://orcid.org/0000-0003-2686-8732
Takahashi, Masato
Mukai, Hirofumi
Yamanaka, Takashi
Egawa, Chiyomi
Sakata, Yukinori
Ikezawa, Hiroki
Matsuoka, Toshiyuki
Tsurutani, Junji
Funding for this research was provided by:
Eisai (None)
Article History
Received: 4 December 2019
Accepted: 26 December 2019
First Online: 16 January 2020
Compliance with ethical standards
:
: K. Inoue received grant from Novartis, Pfizer, Chugai, Daiichi-Sankyo, Parexel/Puma Biotechnology, MSD, Bayer, Eli Lilly, and Eisai, and received personal fee from Eisai, Chugai, Pfizer, and Eli Lilly.M. Takahashi received honoraria from Astrazeneca, Eli lilly, Eisai and Pfizer, and received research funding from Eisai, Kyowa Hakko Kirin, Nippon Kayaku, and Taiho.H. Mukai received honoraria from Eisai Co., Ltd.T. Yamanaka received honoraria from Chugai, Eisai, Daiichi-Sankyo, Novartis, Pfizer, and Taiho.C. Egawa declares no conflict of interest.Y. Sakata, H. Ikezawa, and T. Matsuoka are employees of Eisai Co., Ltd.J. Tsurutani is an adviser of Eisai Co., Ltd., Asahi Kasei Corporation, and Daiich Sankyo, and received honoraria from Eisai Co., Ltd., Taiho Pharmaceutical Co., Ltd., Roche Diagnostics K.K., Novartis Pharma, AstraZeneca K.K., and Kyowa-Kirin.
: Eisai Co., Ltd. reviewed the scientific and ethical validity of the study design. This study was conducted in accordance with the Declaration of Helsinki and Japanese Good Post-Marketing Study Practice (GPSP) which is an authorized standard for post-marketing surveillance. GPSP does not require approval from the institutional review boards of each institution. However, in practice, some institutions may have obtained approval when deemed necessary.
: GPSP does not require approval from each institution’s institutional review board or informed consent from the participating patients. Therefore, obtaining informed consent was not mandatory for this type of study. However, in some institutions, informed consent may have been obtained from participants.