Sagara, Rieko http://orcid.org/0000-0002-1001-6298
Ishigaki, Masahide
Otsuka, Manami
Murayama, Kei
Ida, Hiroyuki
Fernandez, Jovelle
Clinical trials referenced in this document:
Documents that mention this clinical trial
Long-term safety and effectiveness of velaglucerase alfa in Gaucher disease: 6-year interim analysis of a post-marketing surveillance in Japan
https://doi.org/10.1186/s13023-021-02119-2
Funding for this research was provided by:
Takeda Pharmaceutical Company Ltd
Article History
Received: 25 May 2021
Accepted: 6 November 2021
First Online: 4 December 2021
Declarations
:
: This survey protocol was designed based on the ministerial ordinance for the Good Post-marketing Study Practice in Japan. All patients included in this analysis provided written informed consent for their data to be included in this publication. This protocol was reviewed by the Institutional Review Board (IRB) at each medical institution, however, according to the good post-marketing study practice (GPSP) in Japan, this is not a requirement for PMS, and no further ethical approval was required.
: This analysis was performed using data only from patients with GD who consented to their data being included in this publication.
: RS, MI and MO are employees of Takeda Pharmaceutical Company Ltd. JF is an employee of, and owns stock in Takeda Pharmaceutical Company Limited and was formerly employed by, and owns restricted stock in, GlaxoSmithKline as well. KM has nothing to disclose. HI has received honoraria from Sanofi, Takeda Pharmaceutical Company Ltd and JCR Pharmaceuticals Company Ltd; consulting fees from Takeda Pharmaceutical Company Ltd and JCR Pharmaceuticals as well as grants or funds from Sanofi, and Dainippon Sumitomo Pharma Co Ltd.