Comparison · NCT02943785-537240bd
Edoxaban vs Vitamin K Antagonist (VKA): Number of Participants Who Experienced Major Bleeding (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA
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. Edoxaban vs Vitamin K Antagonist (VKA): Number of Participants Who Experienced Major Bleeding (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA. Trial comparisons, record NCT02943785-537240bd. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02943785-537240bd
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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 | 0.137 | 0.114 | 0.165 | wilson | |
| Risk in group 2 | 0.0954 | 0.0759 | 0.119 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0421 | 0.00876 | 0.0755 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.44 | 1.08 | 1.93 | log | |
| Odds ratio, group 1 over group 2 | 1.51 | 1.09 | 2.1 | log | |
| Number needed to treat, for one more participant with the outcome on Edoxaban than on Vitamin K Antagonist (VKA) | 23.8 | 13.2 | 114 | 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 | Edoxaban | Participants randomized to receive the Edoxaban-based regimen which included 60 mg and 30 mg film coated tablets for once-daily oral use, and 15 mg film coated tablet in case of transitioning at the end of treatment. Dosing followed the locally approved label. | 98 | 713 | OG000 |
| Group 2 | Vitamin K Antagonist (VKA) | Participants randomized to receive the VKA-based regimen which included oral VKA tablets as selected and provided by the site and used in accordance with the local label. The Investigator monitored the patient and adjusted the VKA dose to maintain the dose within target. | 68 | 713 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants Who Experienced Major Bleeding (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA
- Description
ISTH Bleeding Criteria for Major Bleeding are defined as clinically overt bleeding that is associated with: a fall in hemoglobin of 2 g/dL (1.24 mmol/L) or more, or a transfusion of 2 or more units of whole blood or packed red blood cells, or symptomatic bleeding into a critical site or organ such as intracranial, intraspinal, intraocular, retroperitoneal, pericardial, intra-articular, or intramuscular with compartment syndrome, or a fatal outcome.
- Time frame
- Baseline through study completion, up to 36 months post-dose
- Population
- Bleeding events were assessed in the ITT Analysis Set.
Source ClinicalTrials.gov
Trial
- Title
- Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF)
- NCT number
- NCT02943785
- Phases
- PHASE3
- Conditions
- Atrial Fibrillation
- Interventions
- Edoxaban-based Regimen, VKA-based Regimen
- Lead sponsor
- Daiichi Sankyo
- Results first posted
- 2022-03-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02943785?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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