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Authors
Inoue, Yoshikazu https://orcid.org/0000-0003-3994-874X
Ogura, Takashi
Azuma, Arata https://orcid.org/0000-0003-0506-9966
Kondoh, Yasuhiro https://orcid.org/0000-0001-7456-5459
Homma, Sakae
Muraishi, Kenya
Ikeda, Rie
Ochiai, Kaori
Sugiyama, Yukihiko
Nukiwa, Toshihiro https://orcid.org/0000-0001-8712-1195
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Clinical Trials BETA
Clinical trials referenced in this document:
nct02607722 at ClinicalTrials.govDocuments that mention this clinical trial
Real-World Safety, Tolerability and Effectiveness of Nintedanib in Patients with Idiopathic Pulmonary Fibrosis: Final Report of Post-marketing Surveillance in Japan
https://doi.org/10.1007/s12325-024-03079-2
Real-World Safety and Tolerability of Nintedanib in Patients with Idiopathic Pulmonary Fibrosis: Interim Report of a Post-Marketing Surveillance in Japan
https://doi.org/10.1007/s12325-022-02411-y
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Funding
Funding for this research was provided by:
Nippon Boehringer Ingelheim Co., Ltd.
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Article History
Received: 2 September 2024
Accepted: 22 November 2024
First Online: 23 December 2024
Declarations
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: Yoshikazu Inoue has received grants from the Japanese Ministry of Health, Labour and Welfare, from the Japan Agency for Medical Research and Development, and from the NHO Respiratory Network; and lecture fees and/or consulting fees from Boehringer Ingelheim, Shionogi and Co., Ltd., Taiho Pharmaceutical Co., Kyorin Pharmaceutical, Galapagos, Roche, Tanabe Mitsubishi, AsahiKasei, Mochida, Chugai, AMGEN, Savara Co., Ltd., CSL Behring, Vicore Pharma AB, Horizon Therapeutics, GSK, AstraZeneca, and Novartis Pharma K.K. Takashi Ogura has received consulting fees from Boehringer Ingelheim, Bristol-Myers Squibb and Taiho Pharmaceutical Co.; and lecture fees or honoraria from Boehringer Ingelheim, Eisai Inc., Kyorin Pharmaceutical Co., Ltd., Shionogi and Co., Ltd. and Teijin Pharma. Arata Azuma has received consulting fees from Toray Co., Ltd.; lecture fees and participation on an advisory board from Boehringer Ingelheim and Taiho Pharmaceutical Co.; and support for travel from Boehringer Ingelheim. Yasuhiro Kondoh has received consulting fees from Boehringer Ingelheim, Chugai Pharmaceutical Co., Ltd., Healios K.K., Janssen Pharmaceutical K.K., Shionogi and Co., Ltd. and Taiho Pharmaceutical Co.; and payments or honoraria from Boehringer Ingelheim, Bristol-Myers Squibb, Eisai Inc., Janssen Pharmaceutical K.K., Kyorin Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma, Novartis Pharma K.K., Shionogi and Co., Ltd. and Teijin Pharma. Sakae Homma has received consulting fees from Boehringer Ingelheim. Kenya Muraishi and Rie Ikeda are employees of Nippon Boehringer Ingelheim Co., Ltd. Kaori Ochiai is an employee of EPS Corporation and is in charge of analysis work on behalf of Nippon Boehringer Ingelheim Co., Ltd. Yukihiko Sugiyama was on a data safety advisory board from Boehringer Ingelheim. Toshihiro Nukiwa has received consulting fees from Boehringer Ingelheim and payments or honoraria from Grifols.
: The study was conducted under the direction of the Ministry of Health, Labour and Welfare (MHLW) and the protocol was approved by the MHLW before its initiation. Participating institutes were contracted by Boehringer Ingelheim. As per the Japanese Pharmaceutical and Medical Device Act, this study was conducted in accordance with the Good Post-marketing Study Practice (GPSP) guidance. Under GPSP regulations, institutional review board approval and patient written informed consent were not required, unless such procedures were specifically required by the participating institutions.
