Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od vs Rivaroxaban Placebo Bid + Aspirin 100 mg od: Number of Participants With an Unplanned Index Limb Revascularization for Recurrent Limb Ischemia (Subsequent Index Leg Revascularization That Was Not Planned or Considered as Part of the Initial Treatment Plan at the Time of Randomization)
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 | 0.178 | 0.165 | 0.191 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.2 | 0.186 | 0.214 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.0221 | -0.041 | -0.00316 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.889 | 0.804 | 0.983 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.866 | 0.765 | 0.98 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od than on Rivaroxaban Placebo Bid + Aspirin 100 mg od | 45.3 | 24.4 | 317 | 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 | 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) | 584 | 3,286 | OG000 | 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 | 655 | 3,278 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With an Unplanned Index Limb Revascularization for Recurrent Limb Ischemia (Subsequent Index Leg Revascularization That Was Not Planned or Considered as Part of the Initial Treatment Plan at the Time of Randomization) | ClinicalTrials.gov |
| Description | Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered. | ClinicalTrials.gov |
| Time frame | For each participant, the first occurrence of the efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1062.48 days. | ClinicalTrials.gov |
| Population | Intention-to-treat analysis set (ITT Set): Comprised all randomized participants. | 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.