Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal (Urology,Obstetrics,Gynecology)

GlaxoSmithKline475 enrolled

Overview

The purpose of this study is to collect and assess information on safety and efficacy of fondaparinux in patients undergoing abdominal surgery in urology, obstetrics and gynecology departments who are at high risk of venous thromboembolism.

Study Type

OBSERVATIONAL

Enrollment

475

Conditions

Cardiovascular Disease

Interventions

Fondaparinux SodiumDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Patients undergoing abdominal surgery in urology, obstetrics and gynecology departments Exclusion Criteria: * Patients with a history of hypersensitivity to the ingredients of fondaparinux * Patients with bleeding (bleeding in important organs, sucn as retroperitoneal bleed) * Patients with acute bacterial endocarditis * Patients with severe renal impairment

Outcomes

Primary Outcomes

The number of adverse events in Japanese patients treated with fondaparinux

Time frame: 4 months at maximum

Presence or absence of venous thromboembolism after treatment of fondaparinux

Time frame: 4 months at maximum

Data from ClinicalTrials.gov

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