Comparison · NCT00371683-sae
Apixaban 2.5mg BID vs Enoxaparin 30 mg SC Injection q 12 Hours: serious adverse events
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. Apixaban 2.5mg BID vs Enoxaparin 30 mg SC Injection q 12 Hours: serious adverse events. Trial comparisons, record NCT00371683-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00371683-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 | 0.0771 | 0.065 | 0.0912 | wilson | |
| Risk in group 2 | 0.0775 | 0.0653 | 0.0916 | wilson | |
| Risk difference, group 1 minus group 2 | -0.000388 | -0.019 | 0.0182 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.995 | 0.783 | 1.26 | log | |
| Odds ratio, group 1 over group 2 | 0.995 | 0.767 | 1.29 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Apixaban 2.5mg BID than on Enoxaparin 30 mg SC Injection q 12 Hours | 2,580 | 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 2.5mg BID | Apixaban 2.5 mg tablets twice a day (BID) plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72). | 123 | 1,596 | EG000 |
| Group 2 | Enoxaparin 30 mg SC Injection q 12 Hours | Enoxaparin 30 mg subcutaneous (SC) injection every (q) 12 hours (h) plus matching placebo tablets BID for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72). | 123 | 1,588 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- First dose to last dose, plus 2 days for AEs or plus 30 days for SAEs.
Source ClinicalTrials.gov
Trial
- Title
- Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery
- NCT number
- NCT00371683
- Phases
- PHASE3
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism
- Interventions
- Enoxaparin + Placebo, Apixaban + Placebo
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2015-12-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00371683?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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