Comparison · NCT00634270-sae
Stratum 1 vs Stratum 2: 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. Stratum 1 vs Stratum 2: serious adverse events. Trial comparisons, record NCT00634270-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00634270-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 | 0.435 | 0.302 | 0.578 | wilson | |
| Risk in group 2 | 0.333 | 0.138 | 0.609 | wilson | |
| Risk difference, group 1 minus group 2 | 0.101 | -0.205 | 0.343 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.3 | 0.549 | 3.1 | log | |
| Odds ratio, group 1 over group 2 | 1.54 | 0.405 | 5.84 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Stratum 1 than on Stratum 2 | 9.86 | 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 | Stratum 1 | Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity with evidence of progression.~Sirolimus oral solution will be administered orally BID on a continuous dosing schedule (28 days = 1 treatment course) with pharmacokinetically-guided dosing. Disease status will be evaluated using volumetric MRI analysis at regular intervals. | 20 | 46 | EG000 |
| Group 2 | Stratum 2 | Non-randomized, single arm interventional strata for inoperable Plexiform Neurofibromas with potential to cause significant morbidity WITHOUT evidence of progression | 4 | 12 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 4 years
Source ClinicalTrials.gov
Trial
- Title
- A Phase II Study of the mTOR Inhibitor Sirolimus in Neurofibromatosis Type 1 Related Plexiform Neurofibromas
- NCT number
- NCT00634270
- Phases
- PHASE2
- Conditions
- Neurofibromatosis Type 1
- Interventions
- Sirolimus
- Lead sponsor
- University of Alabama at Birmingham
- Results first posted
- 2017-02-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00634270?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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