Special Drug Use Investigation for ARIXTRA® (Fondaparinux) Injection

Completed

• Conditions: Thromboembolism

• Registration Number: NCT01420809
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This post-marketing surveillance study was designed to collect and assess the information on proper use of fondaparinux injection, such as the safety and efficacy under actual use conditions, in subjects undergoing orthopedic surgery of the lower limb at high risk of developing venous thromboembolism.

(ARIXTRA® is a trademark of the GlaxoSmithKline group of companies.)

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2009-05
• Study Completion: 2009-08
• Study First Submitted: 2011-07-28
• Study First Submitted QC: 2011-08-18
• Study First Posted: 2011-08-22
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1280

Inclusion Criteria

• Subjects undergo orthopedic surgery of the lower limb at high risk of developing venous thromboembolism

Exclusion Criteria

• Not applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events of bleeding	3 months
The number of incidences of adverse events in Japanese subjects undergoing orthopedic surgery of the lower limb	3 months
Presence or absence of venous thromboembolism after treatment of fondaparinux	3 months