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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.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with VTE treated with fondaparinux | Patients with VTE treated with fondaparinux |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fondaparinux sodium | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse drug reaction | 3 months | |
| Number of patients with any serious adverse event | 3 months | |
| Number of patients with any hemorrhagic adverse event | 3 months | |
| Presence or absence of reoccurrence of VTE | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Japanese patients with acute pulmonary thromboembolism or acute deep venous thrombosis whose body weight is 100 kg or more, or to whom fondaparinux was injected 10 mg/day.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Term |
|---|---|
| D001259 | Ataxia |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077425 | Fondaparinux |
| ID | Term |
|---|---|
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |