Comparison · NCT00414648-sae
Sirolimus Treatment Arm vs Placebo Treatment Arm: 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 Treatment Arm vs Placebo Treatment Arm: serious adverse events. Trial comparisons, record NCT00414648-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00414648-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 | 0.5 | 0.361 | 0.639 | wilson | |
| Risk in group 2 | 0.419 | 0.284 | 0.567 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0814 | -0.122 | 0.275 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.19 | 0.757 | 1.88 | log | |
| Odds ratio, group 1 over group 2 | 1.39 | 0.601 | 3.21 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Sirolimus Treatment Arm than on Placebo Treatment Arm | 12.3 | 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 Treatment Arm | Participants will receive sirolimus daily for 1 year followed with serial pulmonary functional tests and 6-minute walk tests over a 2-year period. Note: study truncated to 1 year with daily sirolimus in 2010. Second year of follow up eliminated after August 31, 2010. | 23 | 46 | EG000 |
| Group 2 | Placebo Treatment Arm | Participants will receive placebo sirolimus daily for 1 year followed with serial pulmonary functional tests and 6-minute walk tests over a 2-year period. Note: study truncated to 1 year with daily placebo sirolimus in 2010. Second year of follow up eliminated after August 31, 2010. | 18 | 43 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse event data was collected over a 2 year period (12 month treatment period and 12 month observation period).
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety of Sirolimus in LAM
- NCT number
- NCT00414648
- Phases
- PHASE3
- Conditions
- Lymphangioleiomyomatosis
- Interventions
- Sirolimus, Placebo
- Lead sponsor
- University of Cincinnati
- Results first posted
- 2023-11-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00414648?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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