Comparison · NCT00843492-4dbca45e
Nadroparin vs Fondaparinux: Number of Participants With Venous Thromboembolism (VTE) or Death up to the Time of Complete Mobilization
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. Nadroparin vs Fondaparinux: Number of Participants With Venous Thromboembolism (VTE) or Death up to the Time of Complete Mobilization. Trial comparisons, record NCT00843492-4dbca45e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00843492-4dbca45e
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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 | 0.0819 | 0.0623 | 0.107 | wilson | |
| Risk in group 2 | 0.0257 | 0.0156 | 0.0419 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0562 | 0.0308 | 0.0832 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 3.19 | 1.81 | 5.63 | log | |
| Odds ratio, group 1 over group 2 | 3.38 | 1.87 | 6.12 | log | |
| Number needed to treat, for one more participant with the outcome on Nadroparin than on Fondaparinux | 17.8 | 12 | 32.5 | from the risk difference interval |
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 | Nadroparin | 2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters \[ml\] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3) | 48 | 586 | OG000 |
| Group 2 | Fondaparinux | 2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3) | 15 | 584 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Venous Thromboembolism (VTE) or Death up to the Time of Complete Mobilization
- Description
VTE is defined as asymptomatic deep vein thrombosis (DVT: the formation of a blood clot in a deep vein) detected by systematic compression ultrasonography, symptomatic DVT, or symptomatic fatal or non-fatal pulmonary embolism (PE). An embolism is a clot in the blood that forms and blocks a blood vessel. A pulmonary embolism is a blood clot that has travelled from elsewhere in the body through the blood stream to block the main artery of the lung or one of its branches. All venous thromboembolic events and deaths were adjudicated by the independent Central Adjudication Committee (CAC).
- Time frame
- Day 1 to complete mobilization plus 2 days (average of 35.9 study days)
- Population
Intent-to-Treat (ITT) Population: all randomized participants with a VTE status or experiencing death. Participants without evaluation of the primary endpoint in the timeframe requested by the protocol were considered as missing data and therefore not included in the primary efficacy analysis.
Source ClinicalTrials.gov
Trial
- Title
A Study to Evaluate the Efficacy and Safety of Fondaparinux for the Prevention of Venous Blood Clots in Patients With a Plaster Cast or Other Type of Immobilization for a Below-knee Injury Not Needing Surgery
- NCT number
- NCT00843492
- Phases
- PHASE3
- Conditions
- Thrombosis, Venous
- Interventions
- Fondaparinux sodium, Nadroparin
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2012-07-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00843492?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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