Comparison · NCT00085540-sae
Phase 1 Dose Escalation - Romidepsin vs Phase 2 Dose From Phase 1 - Romidepsin: serious adverse events
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. Phase 1 Dose Escalation - Romidepsin vs Phase 2 Dose From Phase 1 - Romidepsin: serious adverse events. Trial comparisons, record NCT00085540-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00085540-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 | 0 | 0.324 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0876 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0876 | 0.324 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
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 | Phase 1 Dose Escalation - Romidepsin | Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Dose escalation two dose levels:~Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2~Pharmacokinetics~depsipeptide: Given IV | 0 | 8 | EG000 |
| Group 2 | Phase 2 Dose From Phase 1 - Romidepsin | Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity~Romidepsin (depsipeptide): 13.3mg/m2~depsipeptide: Given IV | 0 | 40 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 2 years
Source ClinicalTrials.gov
Trial
- Title
- FR901228 in Treating Patients With Recurrent High-Grade Gliomas
- NCT number
- NCT00085540
- Phases
- PHASE1, PHASE2
- Conditions
- Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma, Adult Giant Cell Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor
- Interventions
- depsipeptide
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2016-11-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00085540?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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