Comparison · NCT00643201-sae
Apixaban vs Enoxaparin/Warfarin: 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 vs Enoxaparin/Warfarin: serious adverse events. Trial comparisons, record NCT00643201-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00643201-sae
On this page
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 | 0.156 | 0.143 | 0.17 | wilson | |
| Risk in group 2 | 0.152 | 0.139 | 0.167 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00336 | -0.016 | 0.0227 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.902 | 1.16 | log | |
| Odds ratio, group 1 over group 2 | 1.03 | 0.885 | 1.19 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Apixaban than on Enoxaparin/Warfarin | 298 | 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 | Apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months~Placebo for enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2~Placebo for warfarin: tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months | 417 | 2,676 | EG000 |
| Group 2 | Enoxaparin/Warfarin | Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until INR ≥2~warfarin: tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months~Placebo for apixaban: tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months | 410 | 2,689 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day 1 up to 24 Weeks + 2 Days or 355 Days (for those participants who discontinued early)/
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism
- NCT number
- NCT00643201
- Phases
- PHASE3
- Conditions
- Venous Thrombosis
- Interventions
- Enoxaparin, warfarin, Placebo for apixaban, Placebo for enoxaparin, Placebo for warfarin, apixaban
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2014-04-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00643201?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT00643201-sae