Comparison · NCT01499953-dfd8006e
Rivaroxaban vs Fondaparinux: Composite Primary Efficacy Outcome
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Rivaroxaban vs Fondaparinux: Composite Primary Efficacy Outcome. Trial comparisons, record NCT01499953-dfd8006e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01499953-dfd8006e
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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 | 0.0711 | 0.0436 | 0.114 | wilson | |
| Risk in group 2 | 0.067 | 0.041 | 0.108 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00413 | -0.0449 | 0.0543 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.06 | 0.532 | 2.12 | log | |
| Odds ratio, group 1 over group 2 | 1.07 | 0.508 | 2.24 | log | |
| Number needed to treat, for one more participant with the outcome on Rivaroxaban than on Fondaparinux | 242 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Rivaroxaban | Rivaroxaban for 45 days oral dose: 10 mg OD~Rivaroxaban: Dose: 10 mg Duration: 45 (±5) days Frequency: once daily Application: oral | 15 | 211 | OG000 |
| Group 2 | Fondaparinux | Fondaparinux for 45 days subcutaneous application: 2,5 mg OD~Fondaparinux: Fondaparinux Dose: 2.5 mg Duration: 45 (±5) days Frequency: once daily Application: subcutaneous | 15 | 224 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Composite Primary Efficacy Outcome
- Description
For this, secondary efficacy outcomes were the composite primary efficacy outcome up to Day 90 and the following outcomes up to Day 45 and Day 90: each component of the primary efficacy outcome, the rate of major VTE (composite of symptomatic pulmonary embolism or symptomatic proximal DVT or VTE-related death) and the rates of surgery for SVT.
- Time frame
- 90 +/- 10 days
- Population
- Per protocol analysis set
Source ClinicalTrials.gov
Trial
- Title
- Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux
- NCT number
- NCT01499953
- Phases
- PHASE3
- Conditions
- Superficial Vein Thrombosis
- Interventions
- Rivaroxaban, Fondaparinux
- Lead sponsor
- GWT-TUD GmbH
- Results first posted
- 2023-05-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01499953?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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