NCT01428531
Completed
Not Applicable
Special Drug Use Investigation for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment
Overview
- Phase
- Not Applicable
- Intervention
- Fondaparinux Sodium
- Conditions
- Ataxia
- Sponsor
- GlaxoSmithKline
- Enrollment
- 200
- Primary Endpoint
- Number of patients with adverse drug reaction
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.)
Investigators
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 prescribed fondaparinux
Intervention: Fondaparinux Sodium
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
Similar Trials
Completed
Not Applicable
Special Drug Use Investigation for ARIXTRA® (Fondaparinux) InjectionThromboembolismNCT01420809GlaxoSmithKline1,280
Completed
Not Applicable
Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox)VaricellaNCT01390857GlaxoSmithKline379
Completed
Not Applicable
Special Drug Use Investigation (Retrospective) for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment (Over 100kg)AtaxiaNCT01428544GlaxoSmithKline5
Completed
Not Applicable
Arnuity® Ellipta® Drug Use InvestigationAsthmaNCT03184480GlaxoSmithKline336
Completed
Not Applicable
Drug Use Investigation for Arepanrix® (H1N1)InfluenzaNCT02069496GlaxoSmithKline3,405