Special Drug Use Investigation for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment

Completed

• Conditions: Ataxia
• Interventions: Drug: Fondaparinux Sodium

• Registration Number: NCT01428531
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this post-marketing surveillance study is to collect and assess information on safety and efficacy of fondaparinux injection in patients with venous thromboembolism (VTE).

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-01
• Study First Submitted QC: 2011-09-01
• Study First Posted: 2011-09-05
• Study Start: 2012-01
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-13
• Last Update Posted: 2015-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients with acute pulmonary thromboembolism or acute deep venous thrombosis
• Fondaparinux injection must be prescribed for the first time

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Exclusion Criteria

• Not applicable

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients prescribed fondaparinux	Fondaparinux Sodium	-

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse drug reaction	3 months
Number of patients with any serious adverse event	3 months
Number of patients with any hemorrhagic adverse event	3 months
Presence or absence of reoccurrence of VTE	3 months