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

GlaxoSmithKline5 enrolled

Overview

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.)

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ataxia

Interventions

Fondaparinux sodiumDRUG

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.

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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