Special Drug Use Investigation (Retrospective) for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment (Over 100kg)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 5
- Primary Endpoint
- Number of patients with any hemorrhagic adverse event
Study 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.)
Study Design
- Study Type
- Observational
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts 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
Arms & Interventions
Patients with VTE treated with fondaparinux
Patients with VTE treated with fondaparinux
Intervention: Fondaparinux sodium (Drug)
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
Secondary Outcomes
No secondary outcomes reported