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Clinical Trials/NCT01428544
NCT01428544
Completed
Not Applicable

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

GlaxoSmithKline0 sites5 target enrollmentMarch 2012
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ConditionsAtaxia
InterventionsFondaparinux sodium
DrugsFondaparinux sodium

Overview

Phase
Not Applicable
Intervention
Fondaparinux sodium
Conditions
Ataxia
Sponsor
GlaxoSmithKline
Enrollment
5
Primary Endpoint
Number of patients with any hemorrhagic adverse event
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

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.)

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
June 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Patients with VTE treated with fondaparinux

Patients with VTE treated with fondaparinux

Intervention: Fondaparinux sodium

Outcomes

Primary Outcomes

Number of patients with any hemorrhagic adverse event

Time Frame: 3 months

Number of patients with any serious adverse event

Time Frame: 3 months

Number of patients with adverse drug reaction

Time Frame: 3 months

Presence or absence of reoccurrence of VTE

Time Frame: 3 months

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