Comparison · NCT01187446-223f63d2
TSEBT Only vs TSEBT Plus Vorinostat: Complete Clinical Response (CCR)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. TSEBT Only vs TSEBT Plus Vorinostat: Complete Clinical Response (CCR). Trial comparisons, record NCT01187446-223f63d2. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01187446-223f63d2
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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 | 0.214 | 0.0757 | 0.476 | wilson | |
| Risk in group 2 | 0.231 | 0.0818 | 0.503 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0165 | -0.322 | 0.285 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.929 | 0.226 | 3.81 | log | |
| Odds ratio, group 1 over group 2 | 0.909 | 0.148 | 5.58 | log | |
| Number needed to treat, for one fewer participant with the outcome on TSEBT Only than on TSEBT Plus Vorinostat | 60.7 | 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 | TSEBT Only | • TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks. | 3 | 14 | OG000 |
| Group 2 | TSEBT Plus Vorinostat | * TSEBT as 12 grey (Gy), fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment); 4 days each week; for a total of 3 weeks.~* Vorinostat 400 mg/day concurrent and continuing for 8 weeks total. | 3 | 13 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Complete Clinical Response (CCR)
- Description
Complete Clinical Response (CCR) at week 8 as determined by an Modified Severity-Weighted Assessment Tool (mSWAT) score of 0. mSWAT is an objective, quantitative, severity-weighted method to assess the extent of mycosis fungoides (MF) lesions, and is determined by total body surface area (%TBSA) of the lesion by a severity-weighting factor (1 = patch; 2 = plaque; 4 = tumor). O% TBSA produces a product of 0, indicating complete response.
- Time frame
- Week 8
- Population
Source ClinicalTrials.gov
Trial
- Title
- Low-dose (12 Gy) TSEBT+Vorinostat Versus Low-dose TSEBT Monotherapy in Mycosis Fungoides
- NCT number
- NCT01187446
- Phases
- PHASE1, PHASE2
- Conditions
- Cutaneous Lymphoma, Cutaneous T-cell Lymphoma
- Interventions
- Total skin electron beam therapy (TSEBT), Vorinostat
- Lead sponsor
- Stanford University
- Results first posted
- 2017-11-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01187446?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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