Comparison · NCT00423319-sae
Apixaban, 2.5 mg BID + Placebo vs Enoxaparin, 40 mg QD + Placebo: 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. Apixaban, 2.5 mg BID + Placebo vs Enoxaparin, 40 mg QD + Placebo: serious adverse events. Trial comparisons, record NCT00423319-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00423319-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 | 0.0688 | 0.0598 | 0.0791 | wilson | |
| Risk in group 2 | 0.0647 | 0.056 | 0.0747 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00415 | -0.00929 | 0.0176 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.06 | 0.871 | 1.3 | log | |
| Odds ratio, group 1 over group 2 | 1.07 | 0.862 | 1.33 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Apixaban, 2.5 mg BID + Placebo than on Enoxaparin, 40 mg QD + Placebo | 241 | 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 | Apixaban, 2.5 mg BID + Placebo | Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD) | 184 | 2,673 | EG000 |
| Group 2 | Enoxaparin, 40 mg QD + Placebo | Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID | 172 | 2,659 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery (ADVANCE-3)
- NCT number
- NCT00423319
- Phases
- PHASE3
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism
- Interventions
- Enoxaparin, Apixaban, Enoxaparin-matching placebo, Apixaban-matching placebo
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2014-05-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00423319?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.govNone 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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