Comparison · NCT03047213-sae
Treatment (Sapanisertib): TSC Mutation 1 vs TSC Mutation 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. Treatment (Sapanisertib): TSC Mutation 1 vs TSC Mutation 2: serious adverse events. Trial comparisons, record NCT03047213-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03047213-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 | 0.254 | 0.746 | wilson | |
| Risk in group 2 | 0.667 | 0.208 | 0.939 | wilson | |
| Risk difference, group 1 minus group 2 | -0.167 | -0.533 | 0.354 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.75 | 0.281 | 2 | log | |
| Odds ratio, group 1 over group 2 | 0.5 | 0.0352 | 7.1 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Treatment (Sapanisertib): TSC Mutation 1 than on TSC Mutation 2 | 6 | 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 | Treatment (Sapanisertib): TSC Mutation 1 | Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Sapanisertib: Given PO | 6 | 12 | EG000 |
| Group 2 | TSC Mutation 2 | Patients receive sapanisertib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Sapanisertib: Given PO | 2 | 3 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 9 months
Source ClinicalTrials.gov
Trial
- Title
- Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations
- NCT number
- NCT03047213
- Phases
- PHASE2
- Conditions
Locally Advanced Bladder Urothelial Carcinoma, Metastatic Transitional Cell Carcinoma, Metastatic Urothelial Carcinoma, Recurrent Bladder Carcinoma, Stage III Bladder Urothelial Carcinoma AJCC v6 and v7, Stage IV Bladder Urothelial Carcinoma AJCC v7
- Interventions
- Sapanisertib
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2025-02-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03047213?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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