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

GlaxoSmithKline200 enrolled

Overview

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.)

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Ataxia

Interventions

Fondaparinux SodiumDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of patients with adverse drug reaction

Time frame: 3 months

Number of patients with any serious adverse event

Time frame: 3 months

Number of patients with any hemorrhagic adverse event

Time frame: 3 months

Presence or absence of reoccurrence of VTE

Time frame: 3 months

Data from ClinicalTrials.gov

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