Comparison · NCT01780987-d52c385f
Apixaban vs Unfractionated Heparin (UFH)/Warfarin: Number of Participants With Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］ or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period
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 vs Unfractionated Heparin (UFH)/Warfarin: Number of Participants With Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］ or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period. Trial comparisons, record NCT01780987-d52c385f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01780987-d52c385f
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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 | 0.075 | 0.0258 | 0.199 | wilson | |
| Risk in group 2 | 0.282 | 0.165 | 0.438 | wilson | |
| Risk difference, group 1 minus group 2 | -0.207 | -0.37 | -0.0371 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.266 | 0.0803 | 0.881 | log | |
| Odds ratio, group 1 over group 2 | 0.206 | 0.0526 | 0.81 | log | |
| Number needed to treat, for one fewer participant with the outcome on Apixaban than on Unfractionated Heparin (UFH)/Warfarin | 4.83 | 2.7 | 27 | 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 | Apixaban | Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks. | 3 | 40 | OG000 |
| Group 2 | Unfractionated Heparin (UFH)/Warfarin | UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks. | 11 | 39 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
Number of Participants With Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］ or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period
- Description
Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event. CRNM bleeding event was defined as an acute clinically overt bleeding that did not satisfy the definition of major bleeding and that led to either hospitalization, physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy.
- Time frame
- Baseline to Week 24
- Population
- The safety analysis set (SAS) consisted of all treated participants.
Source ClinicalTrials.gov
Trial
- Title
- AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients
- NCT number
- NCT01780987
- Phases
- PHASE3
- Conditions
- Deep Vein Thrombosis, Pulmonary Embolism
- Interventions
- Apixaban, Unfractionated Heparin (UFH), Warfarin
- Lead sponsor
- Pfizer
- Results first posted
- 2016-06-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01780987?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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