Special Drug Use Investigation (Retrospective) for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment (Over 100kg)

Ataxia Clinical Trial

Official title:

Special Drug Use Investigation (Retrospective) for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment (Over 100kg)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428544
• Other study ID #: 115490
• Status: Completed
• Phase: N/A
• First received: September 1, 2011
• Last updated: July 13, 2015
• Start date: March 2012
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial Summary

The purpose of this post-marketing surveillance study is to collect and assess information retrospectively on safety and effectiveness of fondaparinux injection in patients with venous thromboembolism (VTE) whose body weight is 100 kilograms (kg) or more, or to whom fondaparinux was injected 10 mg/day.

("Arixtra" is a trademark of the GlaxoSmithKline group of companies.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with acute pulmonary thromboembolism or acute deep venous thrombosis

• Fondaparinux injection must be prescribed for the first time

Exclusion Criteria:

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Ataxia
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Fondaparinux sodium
For patients whose body weight is 100 kg or more, fondaparinux is injected 10 mg subcutaneously once daily for treatment of acute pulmonary thromboembolism or acute deep venous thrombosis.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with adverse drug reaction		3 months	No
Primary	Number of patients with any serious adverse event		3 months	No
Primary	Number of patients with any hemorrhagic adverse event		3 months	No
Primary	Presence or absence of reoccurrence of VTE		3 months	No