Sugiyama, Toru http://orcid.org/0000-0002-2385-9040
Katsumata, Noriyuki http://orcid.org/0000-0001-8863-5921
Toita, Takafumi http://orcid.org/0000-0003-3907-0228
Ura, Masako http://orcid.org/0000-0001-8661-8765
Shimizu, Ayaka http://orcid.org/0000-0001-8597-1241
Kamijima, Shuichi http://orcid.org/0000-0002-1642-4495
Aoki, Daisuke http://orcid.org/0000-0002-9596-8326
Funding for this research was provided by:
Chugai Pharmaceutical Co., Ltd.
Article History
Received: 22 December 2021
Accepted: 23 May 2022
First Online: 27 June 2022
Declarations
:
: Toru Sugiyama has received consultancy fees from Chugai Pharmaceutical Co., Ltd.; Noriyuki Katsumata has received consultancy fees from Nippon Zoki; Takafumi Toita has no conflicts of interest to declare; Masako Ura, Ayaka Shimizu, and Shuichi Kamijima are employees of Chugai Pharmaceutical Co., Ltd. and Daisuke Aoki has received research grants from Takeda, and consultancy fees and honoraria for speaking engagements from Takeda, Chugai Pharmaceutical Co., Ltd., AstraZeneca, and MSD.
: The post-marketing surveillance study was conducted in accordance with the STROBE Statement, and the Japanese regulatory requirements stipulated in the GPSP Ministerial Ordinance in Japan. The requirement for IRB/IEC approval was waived under GPSP. Although the need for informed consent to participate in the post-marketing surveillance study was also waived under GPSP, informed consent was obtained for all patients receiving bevacizumab according to the product label. The case series study was conducted in compliance with the Declaration of Helsinki and the Ethical Guidelines for Medical Research in Humans, and approved by the IRB/IEC of the Non-Profit Organization MINS, St. Mary’s Hospital and institutions where patients’ medical records were collected. Written informed consent or opt-out method was applied for all patients according to the Japanese Ethical Guidelines for Medical and Health Research Involving Human Subjects.