Comparison · NCT04508023-d333cd08
Rivaroxaban 10 Milligrams (mg) vs Placebo: Number of Participants With Time to First Occurrence of Major Bleeding Based on a Modification of the ISTH Criteria
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. Rivaroxaban 10 Milligrams (mg) vs Placebo: Number of Participants With Time to First Occurrence of Major Bleeding Based on a Modification of the ISTH Criteria. Trial comparisons, record NCT04508023-d333cd08. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04508023-d333cd08
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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 | 0.00167 | 0.000295 | 0.0094 | wilson | |
| Risk in group 2 | 0 | 0 | 0.00638 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00167 | -0.00486 | 0.0094 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one more participant with the outcome on Rivaroxaban 10 Milligrams (mg) than on Placebo | 599 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Rivaroxaban 10 Milligrams (mg) | Eligible participants with symptomatic coronavirus disease 2019 (COVID-19) who were at risk of venous and arterial thrombotic complications, received rivaroxaban 10 mg, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician. | 1 | 599 | OG000 |
| Group 2 | Placebo | Eligible participants with symptomatic COVID-19 who were at risk of venous and arterial thrombotic complications, received placebo matching to rivaroxaban, orally, once daily throughout the 35 days of double-blind treatment period along with ongoing standard of care medications for COVID-19 at the discretion of the treating physician. | 0 | 598 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Time to First Occurrence of Major Bleeding Based on a Modification of the ISTH Criteria
- Description
Number of participants with time to first occurrence of the major bleeding based on a modification of the ISTH criteria were reported. Major bleeding is defined as clinically overt bleeding that is associated with a reduction in hemoglobin of 2 grams per deciliter (g/dL) or more, or a transfusion of 2 or more units of packed red blood cells or whole blood, or occurrence at a critical site defined as intracranial, intra-spinal, intraocular, pericardial, intra-articular, intra-muscular with compartment syndrome, retroperitoneal, or fatal outcome.
- Time frame
- Up to Day 35
- Population
- The safety analysis set included participants in ITT who received at least 1 dose of study intervention.
Source ClinicalTrials.gov
Trial
- Title
A Study of Rivaroxaban to Reduce the Risk of Major Venous and Arterial Thrombotic Events, Hospitalization and Death in Medically Ill Outpatients With Acute, Symptomatic Coronavirus Disease 2019 (COVID-19) Infection
- NCT number
- NCT04508023
- Phases
- PHASE3
- Conditions
- Coronavirus Disease 2019 (COVID-19)
- Interventions
- Rivaroxaban, Placebo, Standard of Care (SOC)
- Lead sponsor
- Janssen Research & Development, LLC
- Results first posted
- 2023-07-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04508023?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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