臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 09, 2022
Last modified on	April. 24, 2024
Trial ID	jRCT2031220503

Scientific Title	Ezharmia Tablet Post-marketing Surveillance
Public Title	Ezharmia Tablet Post-marketing Surveillance

Contact for Scientific Queries	Name	Tanabe Hirokazu
	Affiliation	Daiichi Sankyo Co.,Ltd.
	Address	3-5-1,Nihonbashi Honcho,Chuo-ku,Tokyo
	Telephone	+81-3-6225-1059
	E-mail	contact_gpsp@daiichisankyo.co.jp
Contact for Public Queries	Name	Contact for GPSP
	Affiliation	Daiichi Sankyo Co.,Ltd.
	Address	3-5-1,Nihonbashi Honcho,Chuo-ku,Tokyo
	Telephone	+81-362251059
	E-mail	contact_gpsp@daiichisankyo.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Dec. 20, 2022
Actual date of first enrollment
Target sample size		150
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	All patients who start receiving Ezharmia Tablet during the registration period.
	Exclusion Criteria	None
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Relapsed or refractory Adult T-cell leukemia/lymphoma (ATL)
Intervention(s)		none
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Cumulative incidence of AEs (safety specifications of the survey and other AEs)
Secondary Outcome(s)

Primary Sponsor	Daiichi Sankyo Co.,Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	none
Address	none, Tokyo
Telephone
E-Mail
Approval Status
Date of approval

Plan to share IPD	Yes
Plan description	Summary: To support scientific and legitimate activities of scientific researchers and medical researchers, de-identified individual data and related documents can be requested. The data and related documents will be provided according to defined procedures, and the patient's data privacy will be protected. When to be shared: The data will be shared from 36 months after the publication of the main results Conditions to grant access to data: Must be request from the scientific researchers and medical researchers, who will use them to perform legitimate research. Data Protection Law must be obeyed and the request for data shall not extend beyond the limitation of research participants' consent.

Plan to share IPD

Yes

Plan description

Summary: To support scientific and legitimate activities of scientific researchers and medical researchers, de-identified individual data and related documents can be requested. The data and related documents will be provided according to defined procedures, and the patient's data privacy will be protected. When to be shared: The data will be shared from 36 months after the publication of the main results Conditions to grant access to data: Must be request from the scientific researchers and medical researchers, who will use them to perform legitimate research. Data Protection Law must be obeyed and the request for data shall not extend beyond the limitation of research participants' consent.

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	April. 24, 2024	(this page)	Changes
2	Dec. 26, 2022	Detail	Changes
1	Dec. 09, 2022	Detail

List of change history