Asundexian vs Apixaban: Number of Participants With Minor Bleeding
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.0254 | 0.022 | 0.0292 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.043 | 0.0386 | 0.0479 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.0177 | -0.0236 | -0.0118 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.589 | 0.493 | 0.704 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.578 | 0.481 | 0.695 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Asundexian than on Apixaban | 56.5 | 42.4 | 84.5 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
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 | Source |
|---|---|---|---|---|---|---|
| Group 1 | Asundexian | Participants received asundexian 50 mg once a day (OD) and apixaban matching placebo. | 187 | 7,373 | OG000 | ClinicalTrials.gov |
| Group 2 | Apixaban | Participants received apixaban 5 mg twice a day (BID) or reduced dose 2.5 mg BID and asundexian matching placebo. | 317 | 7,364 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With Minor Bleeding | ClinicalTrials.gov |
| Description | The assessment was based on the cause-specific hazard ratio (csHR), comparing asundexian with apixaban which is based on time to first event.~All other overt bleeding episodes not meeting the criteria for ISTH major or clinically relevant non-major bleeding were classified as minor bleeding (for example, bleeding from a minor wound that does not prompt a treatment for the bleeding, for instance with surgical hemostasis, or epistaxis that does not require a medical treatment for bleeding or a change in antithrombotic therapy). | ClinicalTrials.gov |
| Time frame | Approximately 12 months | ClinicalTrials.gov |
| Population | aSAF | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke | ClinicalTrials.gov |
| NCT number | NCT05643573 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Prevention of Stroke or Systemic Embolism, Atrial Fibrillation | ClinicalTrials.gov |
| Interventions | Asundexian (BAY2433334), Apixaban, Asundexian matching placebo, Apixaban matching placebo | ClinicalTrials.gov |
| Lead sponsor | Bayer | ClinicalTrials.gov |
| Results first posted | 2024-12-09 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT05643573?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.