Comparison · NCT00443053-c664514d
Fondaparinux 2.5 mg vs Placebo: Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Fondaparinux 2.5 mg vs Placebo: Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47. Trial comparisons, record NCT00443053-c664514d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00443053-c664514d
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.00866 | 0.00507 | 0.0148 | wilson | |
| Risk in group 2 | 0.0587 | 0.0479 | 0.0717 | wilson | |
| Risk difference, group 1 minus group 2 | -0.05 | -0.0636 | -0.0376 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.148 | 0.0828 | 0.263 | log | |
| Odds ratio, group 1 over group 2 | 0.14 | 0.0779 | 0.252 | log | |
| Number needed to treat, for one fewer participant with the outcome on Fondaparinux 2.5 mg than on Placebo | 20 | 15.7 | 26.6 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Fondaparinux 2.5 mg | Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days | 13 | 1,502 | OG000 |
| Group 2 | Placebo | Matching placebo | 88 | 1,500 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47
- Description
VTE was defined as a composite of symptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), symptomatic extension of superficial vein thrombosis (SVT), or symptomatic recurrence of SVT. All VTEs were confirmed by objective tests and then adjudicated by an independent central adjudication committee (CAC), whose members were blinded to treatment assignment.
- Time frame
- Baseline to Day 47
- Population
- Intent-to-Treat (ITT) Population: all randomized participants
Source ClinicalTrials.gov
Trial
- Title
- Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis)
- NCT number
- NCT00443053
- Phases
- PHASE3
- Conditions
- Thrombosis, Venous
- Interventions
- Fondaparinux 2.5mg or placebo
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2010-08-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00443053?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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