Special Drug Use Investigation for ARIXTRA® (Fondaparinux) Injection

N/ACompletedNCT01420809

GlaxoSmithKline1,280 enrolled

Overview

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.)

Study Type

OBSERVATIONAL

Enrollment

1,280

Conditions

Thromboembolism

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects undergo orthopedic surgery of the lower limb at high risk of developing venous thromboembolism Exclusion Criteria: * Not applicable

Outcomes

Primary Outcomes

The number of incidences of adverse events in Japanese subjects undergoing orthopedic surgery of the lower limb

Time frame: 3 months

Occurrence of adverse events of bleeding

Time frame: 3 months

Presence or absence of venous thromboembolism after treatment of fondaparinux

Time frame: 3 months

Data from ClinicalTrials.gov

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