Doi, Toshihiko
Iwasa, Satoru
Muro, Kei
Satoh, Taroh
Hironaka, Shuichi
Esaki, Taito
Nishina, Tomohiro
Hara, Hiroki
Machida, Nozomu
Komatsu, Yoshito
Shimada, Yasuhiro
Otsu, Satoshi
Shimizu, Shin
Watanabe, Morihiro
Funding for this research was provided by:
Merck KGaA
Pfizer
Article History
Received: 20 September 2018
Accepted: 21 November 2018
First Online: 4 December 2018
Compliance with ethical standards
:
: TD has received research funding from AbbVie, Astellas Pharma, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Chugai Pharma, Daiichi Sankyo, IQVIA, Janssen, Kyowa Hakko Kirin, Lilly Japan, MSD, Merck Serono, Novartis, Pfizer, Sumitomo Group Takeda, and Taiho Pharmaceutical, and reports consulting roles for Amgen, Chugai Pharma, Daiichi Sankyo, Kyowa Hakko Kirin, Lilly Japan, MSD, Sumitomo Dainippon, and Taiho Pharmaceutical. SI reports honoraria from Chugai Pharma and Takeda, and has received research funding from AbbVie, AstraZeneca, Astellas, Bayer, Chugai Pharma, Daiichi Sankyo, Eisai, Lilly, Merck Serono, Nano Carrier, Novartis, Ono Pharmaceutical, Otsuka, Sanofi, Sumitomo Dainippon, Taiho Pharmaceutical, and Teijin. KM reports honoraria from Chugai Pharma, Merck Serono, Takeda, Taiho Pharmaceutical, and Yakult. TS reports honoraria and consulting or advisory roles for Bristol-Myers Squibb, Chugai Pharma, and Merck Serono; TS also reports consulting or advisory roles for Lilly and has received research funding from Chugai Pharma and Yakult. SH reports honoraria from Novartis, Taiho Pharmaceutical, Takeda, and Yakult, and reports consulting or advisory roles for Lilly and Yakult. TE has received research funding from Merck Serono. TN reports honoraria from Merck Serono. HH reports honoraria from Chugai Pharma, Lilly, Merck Serono, Ono Pharmaceutical, Taiho Pharmaceutical, Takeda, and Yakult, and reports consulting or advisory roles from Chugai Pharma, MSD, Merck Serono, and Ono Pharmaceutical. HH has received research funding from AstraZeneca, Boehringer Ingelheim, Chugai Pharma, Daiichi Sankyo, Eisai, Incyte, Lilly, LSK BioPharma, MSD, Merck Serono, Ono Pharmaceutical, Pfizer, Sumitomo Dainippon, Taiho Pharmaceutical, and Takeda. NM and SO have no disclosures to report. YK reports honoraria and speaker services for Bayer, Novartis, and Pfizer; YK also reports speaker services for Chugai Pharma, Lilly, Merck Serono, and Taiho Pharmaceutical, and research funding from Bayer, Chugai Pharma, Lilly, MSD, Novartis, Ono Pharmaceutical, Taiho, and Yakult. YS reports honoraria from Bayer Yakuhin, Chugai Pharma, Daiichi Sankyo, Lilly, Merck Serono, Novartis, Ono Pharmaceutical, Taiho Pharmaceutical, Takeda, and Yakult; YS has also received research funding from Chugai Pharma, Lilly, Merck Serono, MSD, and Taiho Pharmaceutical. SS and MW are employees of Merck Serono.
: The trial was conducted in accordance with the ethics principles of the Declaration of Helsinki and the International Council on Harmonisation Guidelines on Good Clinical Practice (GCP) or Japanese Ministerial Ordinance on GCP. The protocol was approved by the institutional review board or independent ethics committee of each center. All patients provided written informed consent before enrollment.