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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01428544
Enrollment
5
Registered
2011-09-05
Start date
2012-03-31
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 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.)

Interventions

For patients whose body weight is 100 kg or more, fondaparinux is injected 10 mg subcutaneously once daily for treatment of acute pulmonary thromboembolism or acute deep venous thrombosis.

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

MeasureTime frame
Presence or absence of reoccurrence of VTE3 months
Number of patients with adverse drug reaction3 months
Number of patients with any serious adverse event3 months
Number of patients with any hemorrhagic adverse event3 months

Outcome results

None listed

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