Comparison · NCT02806947-sae
Sirolimus vs Prednisone: 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. Sirolimus vs Prednisone: serious adverse events. Trial comparisons, record NCT02806947-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02806947-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 | 0.138 | 0.0716 | 0.249 | wilson | |
| Risk in group 2 | 0.0469 | 0.0161 | 0.129 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0911 | -0.0145 | 0.207 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.94 | 0.819 | 10.6 | log | |
| Odds ratio, group 1 over group 2 | 3.25 | 0.82 | 12.9 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Sirolimus than on Prednisone | 11 | 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 | Sirolimus | Sirolimus, a steroid-free therapy, will be administered after a diagnosis of standard-risk aGVHD is clinically established.~Sirolimus: Sirolimus will be administered with a starting dose of 6 mg for patients older than 12 years, or 5 mg/m\^2 for patients ≤ 12 years. Trough levels will be routinely measured and sirolimus will be kept at maintenance dosing for target therapeutic levels for minimum duration through Day 56 post-randomization. | 8 | 58 | EG000 |
| Group 2 | Prednisone | Prednisone, standard of care therapy for GVHD, will be administered after a diagnosis of standard-risk aGVHD is clinically established.~Prednisone: Prednisone will be administered at 2mg/kg/day x 3 days, and then tapered according to individual treating clinician judgment. | 3 | 64 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 1 Year Post-randomization
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate Steroid-free Treatment for Standard-Risk aGVHD (BMT CTN 1501)
- NCT number
- NCT02806947
- Phases
- PHASE2
- Conditions
- Acute GVHD
- Interventions
- Sirolimus, Prednisone
- Lead sponsor
- Medical College of Wisconsin
- Results first posted
- 2019-12-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02806947?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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