Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od vs Rivaroxaban Placebo Bid + Aspirin 100 mg od: serious adverse events
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 | 0.291 | 0.276 | 0.307 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.285 | 0.27 | 0.301 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.00575 | -0.0163 | 0.0278 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.945 | 1.1 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.03 | 0.924 | 1.14 | log | ClinicalTrials.gov | |
| Number needed to harm, for one more participant with a serious adverse event on Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od than on Rivaroxaban Placebo Bid + Aspirin 100 mg od | 174 | from the risk difference interval | the interval includes no difference | 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 | Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od | Participants were treated with Rivaroxaban 2.5 mg twice-daily (bid) and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily (od) | 948 | 3,256 | EG000 | ClinicalTrials.gov |
| Group 2 | Rivaroxaban Placebo Bid + Aspirin 100 mg od | Participants were treated with Rivaroxaban-placebo twice-daily and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily | 927 | 3,248 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | From randomization until 2 days following permanent discontinuation of the study drug | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities | ClinicalTrials.gov |
| NCT number | NCT02504216 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Peripheral Artery Disease | ClinicalTrials.gov |
| Interventions | Rivaroxaban (Xarelto, BAY59-7939), Rivaroxaban-Placebo | ClinicalTrials.gov |
| Lead sponsor | Bayer | ClinicalTrials.gov |
| Results first posted | 2020-12-08 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT02504216?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.