Comparison · NCT00439777-sae
Rivaroxaban (Xarelto, BAY59-7939) vs Enoxaparin/VKA: serious adverse events
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. Rivaroxaban (Xarelto, BAY59-7939) vs Enoxaparin/VKA: serious adverse events. Trial comparisons, record NCT00439777-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00439777-sae
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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 | 0.209 | 0.193 | 0.226 | wilson | |
| Risk in group 2 | 0.206 | 0.19 | 0.222 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00313 | -0.0198 | 0.026 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.909 | 1.13 | log | |
| Odds ratio, group 1 over group 2 | 1.02 | 0.887 | 1.17 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Rivaroxaban (Xarelto, BAY59-7939) than on Enoxaparin/VKA | 319 | 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 (Xarelto, BAY59-7939) | Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.) | 504 | 2,412 | EG000 |
| Group 2 | Enoxaparin/VKA | Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0) | 495 | 2,405 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study
- NCT number
- NCT00439777
- Phases
- PHASE3
- Conditions
- Pulmonary Embolism
- Interventions
- Rivaroxaban (Xarelto, BAY59-7939), Enoxaparin overlapping with and followed by VKA
- Lead sponsor
- Bayer
- Results first posted
- 2013-01-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00439777?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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