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Comparison · NCT00362232-sae

Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939) vs Enoxaparin 30 mg Twice a Day (Bid): serious adverse events

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939) vs Enoxaparin 30 mg Twice a Day (Bid): serious adverse events. Trial comparisons, record NCT00362232-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00362232-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.06950.05780.0833wilson
Risk in group 20.08690.07370.102wilson
Risk difference, group 1 minus group 2-0.0174-0.03670.00173newcombe hybrid score
Risk ratio, group 1 over group 20.80.6251.02log
Odds ratio, group 1 over group 20.7850.6011.02log
Number needed to treat, for one fewer participant with a serious adverse event on Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939) than on Enoxaparin 30 mg Twice a Day (Bid)57.4from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)
Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
1061,526EG000
Group 2Enoxaparin 30 mg Twice a Day (Bid)Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.1311,508EG001

Harm

What it counts
Total, serious adverse events
Time frame

Source ClinicalTrials.gov

Trial

Title
Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement.
NCT number
NCT00362232
Phases
PHASE3
Conditions
Venous Thromboembolism
Interventions
Rivaroxaban (Xarelto, BAY59-7939), Enoxaparin, Placebo: tablet of Rivaroxaban, Placebo: syringes of Enoxaparin
Lead sponsor
Bayer
Results first posted
2012-06-13

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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