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

NCT ID: NCT01428544

Last Updated: 2015-07-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2015-06-30

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.)

Conditions

Ataxia

Study Design

• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with VTE treated with fondaparinux

Patients with VTE treated with fondaparinux

Fondaparinux sodium

Intervention Type: DRUG

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.

Interventions

Fondaparinux sodium

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.

Intervention Type: DRUG

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

115490

Identifier Type: -

Identifier Source: org_study_id