Comparison · NCT03589976-sae
Sirolimus vs Placebo: 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 vs Placebo: serious adverse events. Trial comparisons, record NCT03589976-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03589976-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 | 0.257 | 0.142 | 0.421 | wilson | |
| Risk in group 2 | 0.167 | 0.047 | 0.448 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0905 | -0.214 | 0.293 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.54 | 0.386 | 6.16 | log | |
| Odds ratio, group 1 over group 2 | 1.73 | 0.317 | 9.44 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Sirolimus than on Placebo | 11.1 | 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 | Sirolimus | 2 mg/day (one 2-mg tablet/day). The dose of sirolimus will be adjusted throughout the trial based on sirolimus plasma levels and the presence of drug-related adverse events. The maximum dose of sirolimus will be6 mg/day (three 2-mg tablets/day).~Sirolimus 2 MG: Dose will be adjusted throughout this trial based on sirolimus plasma levels and the presence of drug-related adverse events. The maximum dose will be 6mg/day. | 9 | 35 | EG000 |
| Group 2 | Placebo | Patients receiving placebo will undergo analog sham level measurements and the number of tablets will be also adjusted to maintain the blinding of the trial.~Placebo: Patients receiving placebo will undergo analog sham level measurements and the number of tablets will be also adjusted to maintain the blinding of the trial. | 2 | 12 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- month 12 after initiation of study drug) (+ 15 days)
Source ClinicalTrials.gov
Trial
- Title
- A Futility Trial of Sirolimus in Multiple System Atrophy
- NCT number
- NCT03589976
- Phases
- PHASE2
- Conditions
- Multiple System Atrophy
- Interventions
- Sirolimus 2 MG, Placebo
- Lead sponsor
- NYU Langone Health
- Results first posted
- 2021-12-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03589976?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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