NCT01420809
Completed
Not Applicable
Special Drug Use Investigation for ARIXTRA® (Fondaparinux) Injection
ConditionsThromboembolism
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Thromboembolism
- Sponsor
- GlaxoSmithKline
- Enrollment
- 1280
- Primary Endpoint
- Occurrence of adverse events of bleeding
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This post-marketing surveillance study was designed to collect and assess the information on proper use of fondaparinux injection, such as the safety and efficacy under actual use conditions, in subjects undergoing orthopedic surgery of the lower limb at high risk of developing venous thromboembolism.
(ARIXTRA® is a trademark of the GlaxoSmithKline group of companies.)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects undergo orthopedic surgery of the lower limb at high risk of developing venous thromboembolism
Exclusion Criteria
- •Not applicable
Outcomes
Primary Outcomes
Occurrence of adverse events of bleeding
Time Frame: 3 months
The number of incidences of adverse events in Japanese subjects undergoing orthopedic surgery of the lower limb
Time Frame: 3 months
Presence or absence of venous thromboembolism after treatment of fondaparinux
Time Frame: 3 months
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