臨床研究等提出・公開システム

Date of registration	May. 17, 2022
Last modified on	April. 28, 2023
Trial ID	jRCT2031220065

Scientific Title	Post-marketing surveillance of LUTATHERA Injection (All Case Study)
Public Title	Post-marketing surveillance of LUTATHERA Injection (All Case Study)

Contact for Scientific Queries	Name	Maki Keiji
	Affiliation	FUJIFILM Toyama Chemical Co., Ltd
	Address	2-14-1, Kyoubashi, Chuo-ku, Tokyo
	Telephone	+81-3-5579-5768
	E-mail	fftc-lutathera-gpsp@fujifilm.com
Contact for Public Queries	Name	Manager of Potmarketing surveillane
	Affiliation	FUJIFILM Toyama Chemical Co., Ltd
	Address	2-14-1, Kyoubashi, Chuo-ku, Tokyo
	Telephone	+81-3-5579-5768
	E-mail	fftc-lutathera-gpsp@fujifilm.com

Recruitment status	Suspended

Anticipated date of first enrollment		Sept. 29, 2021
Actual date of first enrollment		Dec. 20, 2021
Target sample size		300
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	All patients who received LUTATHERA Injection
	Exclusion Criteria	none
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Somatostatin receptor-positive neuroendocrine tumors
Primary Outcome(s)		1. Case composition Number of registered cases, number of cases for which questionnaires were collected, number of cases for safety analysis Number of cases excluded from analysis and reasons for exclusion 2. Safety items The rate of adverse drug reactions The rate of serious adverse drug reactions The rate of adverse drug reactions related to the safety specifications in this study 3. Others Treatment results with this drug
Secondary Outcome(s)		none

Primary Sponsor	FUJIFILM Toyama Chemical Co., Ltd

Name of Certified Review Board	Not Applicable due to Observational Study
Address	Chuo-Ku, Tokyo

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	April. 28, 2023	(this page)	Changes
1	May. 17, 2022	Detail

List of change history