臨床研究等提出・公開システム

Scientific Title	Post-marketing surveillance of AVIGAN tablets 200mg (All-Case Surveillance) - Severe Fever with Thrombocytopenia Syndrome -
Public Title	Post-marketing surveillance of AVIGAN tablets 200mg (SFTS)

Contact for Scientific Queries	Name	PMS Management Supervisor
	Affiliation	FUJIFILM Toyama Chemical Co., Ltd.
	Address	2-14-1, Kyobashi, Chuo-ku, Tokyo, Japan
	Telephone	+81-3-5579-5768
	E-mail	tc-avg@fujifilm.com
Contact for Public Queries	Name	Manager of Post-marketing surveillance
	Affiliation	FUJIFILM Toyama Chemical Co., Ltd.
	Address	2-14-1, Kyobashi, Chuo-ku, Tokyo, Japan
	Telephone	+81-3-5579-5768
	E-mail	tc-avg@fujifilm.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Aug. 15, 2024
Actual date of first enrollment
Target sample size		340
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	All patients treated with AVIGAN tablets 200 mg
	Exclusion Criteria	none
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Severe Fever with Thrombocytopenia Syndrome
Intervention(s)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Incidence of adverse drug reactions Incidence of serious adverse events
Secondary Outcome(s)		Mortality rate (by patient demographics and disease characteristics) [at the time of discontinuation of AVIGAN tablets 200 mg or discharge (including death), cumulative mortality rate up to Day 28 after the start of administration]

Primary Sponsor	FUJIFILM Toyama Chemical Co., Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Not Applicable due to Observational Study
Address	Chuo-ku, Tokyo, Tokyo
Telephone
E-Mail
Approval Status
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none