Comparison · NCT01780987-34ec3c6e
Apixaban vs Unfractionated Heparin (UFH)/Warfarin: Number of Participants With Adjudicated Recurrent Symptomatic Venous Thromboembolism (VTE) [Nonfatal Deep Venous Thrombosis (DVT) or Nonfatal Pulmonary Embolism (PE)] or VTE-Related Death During the Intended Treatment Period
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 Unfractionated Heparin (UFH)/Warfarin: Number of Participants With Adjudicated Recurrent Symptomatic Venous Thromboembolism (VTE) [Nonfatal Deep Venous Thrombosis (DVT) or Nonfatal Pulmonary Embolism (PE)] or VTE-Related Death During the Intended Treatment Period. Trial comparisons, record NCT01780987-34ec3c6e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01780987-34ec3c6e
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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 | 0 | 0.0918 | wilson | |
| Risk in group 2 | 0.025 | 0.00443 | 0.129 | wilson | |
| Risk difference, group 1 minus group 2 | -0.025 | -0.129 | 0.0691 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with the outcome on Apixaban than on Unfractionated Heparin (UFH)/Warfarin | 40 | 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 | 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. | 0 | 38 | 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. | 1 | 40 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
Number of Participants With Adjudicated Recurrent Symptomatic Venous Thromboembolism (VTE) [Nonfatal Deep Venous Thrombosis (DVT) or Nonfatal Pulmonary Embolism (PE)] or VTE-Related Death During the Intended Treatment Period
- Description
VTE-related death was defined as a death caused by documented PE which was diagnosed with objective testing or autopsy, or an unexplained death for which DVT/PE could not be ruled out as the cause. Intended Treatment Period was the period starting on the day of randomization and ending at either 2 days after the last dose of the study drug or Day 168/Week 24, whichever came late.
- Time frame
- Baseline to Week 24
- Population
- Full analysis set (FAS) was defined as all randomized participants. Participants with missing endpoint information were excluded from the analysis.
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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