Document is current

Article History

Received: 1 March 2019

Accepted: 7 November 2019

First Online: 21 November 2019

Ethics approval and consent to participate

: The present manuscript describes data on patients who had been treated in clinical practice setting (not under a clinical trial setting). Essentially, this was a post marketing surveillance, which was undertaken in accord with the Principles of Good Post-marketing Surveillance Practice (GPSP), ordinance of the Japan Ministry of Health, Labour and Welfare (No. 171, dated 20 December 2004). Therefore, informed consent and institutional review board approval were not required in the present surveillance according to standard GPSP guidelines. However, a written contract was made with each of the participating treatment centres before starting the surveillance. All treatment decisions were made independently by the patients’ physicians at the treatment sites.

: Not applicable.

: SM received consultancy fees from AbbVie G.K., Janssen Pharmaceutical K.K., Kyorin Pharmaceutical, Pfizer Japan Inc. and Takeda Pharmaceutical Co., Ltd.; lecture fees from AbbVie G.K., Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma Corporation and Mochida Pharmaceutical Co., Ltd. and research grants from EA Pharma Co., Ltd., Janssen Pharmaceutical K.K, Takeda Pharmaceutical Co., Ltd. and Pfizer Japan Inc. HT received lecture fees from JIMRO Co., Ltd., AbbVie G.K., EA Pharma Co., Ltd., Mochida Pharmaceutical Co., Ltd., Kyorin Pharmaceutical and Mitsubishi Tanabe Pharma Corporation. TS and TO received research grants from JIMRO Co., Ltd. DS received research grants from JIMRO Co., Ltd. ST received research grants from EA Pharma Co., Ltd. MN served as a consultant for JIMRO Co., Ltd. SK and EH are personnel of JIMRO Co., Ltd.