Special Drug Use Investigation for ARIXTRA® (Fondaparinux) Injection

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01420809

Enrollment

1280

Registered

2011-08-22

Start date

2007-09-30

Completion date

2009-08-31

Last updated

2017-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thromboembolism

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.)

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Not applicable

Design outcomes

Primary

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

Outcome results