Comparison · NCT02234843-sae
Comparator Group vs Rivaroxaban Group: 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. Comparator Group vs Rivaroxaban Group: serious adverse events. Trial comparisons, record NCT02234843-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02234843-sae
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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 | 0.216 | 0.16 | 0.286 | wilson | |
| Risk in group 2 | 0.237 | 0.194 | 0.286 | wilson | |
| Risk difference, group 1 minus group 2 | -0.021 | -0.0956 | 0.0606 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.911 | 0.641 | 1.3 | log | |
| Odds ratio, group 1 over group 2 | 0.887 | 0.564 | 1.39 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Comparator Group than on Rivaroxaban Group | 47.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
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 |
|---|---|---|---|---|---|
| Group 1 | Comparator Group | Children randomized to the comparator group will continue with UFH, LMWH or fondaparinux or may switch to VKA therapy. VKA dosages will be adjusted to maintain the INR within the therapeutic range (target 2.5, range 2.0 - 3.0). UFH, LMWH or fondaparinux can be discontinued once the INR is above 2.0 on two separate occasions, 24 hours apart | 35 | 162 | EG000 |
| Group 2 | Rivaroxaban Group | Children randomized to rivaroxaban received either tablet or oral suspension after at least 5 days administration of initial therapy with UFH/LMWH/fondaparinux. Children with body weight of ≥ 20 kg received rivaroxaban tablets or oral suspension. Children with body weight of \< 20 kg received rivaroxaban as oral suspension. | 78 | 329 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- After randomization until last intake of study medication plus 2 days, up to 1 year
Source ClinicalTrials.gov
Trial
- Title
- EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis
- NCT number
- NCT02234843
- Phases
- PHASE3
- Conditions
- Venous Thromboembolism
- Interventions
- Rivaroxaban (Xarelto, BAY59-7939), Rivaroxaban (Xarelto, BAY59-7939), Standard of Care
- Lead sponsor
- Bayer
- Results first posted
- 2020-04-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02234843?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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