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

Completed

• Conditions: Ataxia
• Interventions: Drug: Fondaparinux sodium

• Registration Number: NCT01428544
• Lead Sponsor: GlaxoSmithKline

Brief 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.)

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: 2012-03
• 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: 5

Inclusion Criteria

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

Exclusion Criteria

• Not applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with VTE treated with fondaparinux	Fondaparinux sodium	Patients with VTE treated with fondaparinux

Primary Outcome Measures

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