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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01428531

Enrollment

200

Registered

2011-09-05

Start date

2012-01-31

Completion date

2015-06-30

Last updated

2015-07-15

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

Conditions

Ataxia

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.)

Interventions

DRUGFondaparinux Sodium

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026