Comparison · NCT01106833-sae
Sirolimus, Calcineurin Inhibitor, and Prednisone vs Sirolimus and 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
Cite this record
ConductScience Library. Sirolimus, Calcineurin Inhibitor, and Prednisone vs Sirolimus and Prednisone: serious adverse events. Trial comparisons, record NCT01106833-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01106833-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 | 0.197 | 0.119 | 0.308 | wilson | |
| Risk in group 2 | 0.167 | 0.098 | 0.269 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0303 | -0.0985 | 0.161 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.18 | 0.581 | 2.4 | log | |
| Odds ratio, group 1 over group 2 | 1.23 | 0.515 | 2.92 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Sirolimus, Calcineurin Inhibitor, and Prednisone than on Sirolimus and Prednisone | 33 | 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, Calcineurin Inhibitor, and Prednisone | Sirolimus + calcineurin inhibitor + prednisone~Sirolimus + calcineurin inhibitor + prednisone: The target serum level for sirolimus is 3-12 ng/mL.~The target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.~Prednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day. | 13 | 66 | EG000 |
| Group 2 | Sirolimus and Prednisone | Sirolimus + prednisone~Sirolimus + prednisone: The target serum level for sirolimus is 3-12 ng/mL.~Prednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day. | 12 | 72 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Three years post-randomization
Source ClinicalTrials.gov
Trial
- Title
- Chronic Graft-versus-Host Disease Treatment (BMT CTN 0801)
- NCT number
- NCT01106833
- Phases
- PHASE2, PHASE3
- Conditions
- Chronic GVHD
- Interventions
- Sirolimus + calcineurin inhibitor + prednisone, Sirolimus + prednisone
- Lead sponsor
- Medical College of Wisconsin
- Results first posted
- 2018-08-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01106833?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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