Comparison · NCT04703192-sae
Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) vs Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma: 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. Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) vs Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma: serious adverse events. Trial comparisons, record NCT04703192-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04703192-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 | 0.398 | 0.319 | 0.483 | wilson | |
| Risk in group 2 | 0.682 | 0.473 | 0.836 | wilson | |
| Risk difference, group 1 minus group 2 | -0.283 | -0.457 | -0.0581 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.584 | 0.41 | 0.832 | log | |
| Odds ratio, group 1 over group 2 | 0.309 | 0.118 | 0.809 | log | |
Number needed to treat, for one fewer participant with a serious adverse event on Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) than on Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma | 3.53 | 2.19 | 17.2 | from the risk difference interval |
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 | Cohort 1: Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) | Participants were administered valemetostat tosylate at a dose of 200 mg/day and had an eligible peripheral T-cell lymphoma . | 53 | 133 | EG000 |
| Group 2 | Cohort 2: Relapsed/Refractory Adult T-cell Leukemia/Lymphoma | Participants were administered valemetostat tosylate at a dose of 200 mg/day and had an eligible adult T-cell leukemia/lymphoma. | 15 | 22 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events (AE) were collected from the date of signing the informed consent form up to 30 days after last dose of the study drug, up to 24 months
Source ClinicalTrials.gov
Trial
- Title
- Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
- NCT number
- NCT04703192
- Phases
- PHASE2
- Conditions
- Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma
- Interventions
- Valemetostat Tosylate
- Lead sponsor
- Daiichi Sankyo
- Results first posted
- 2024-07-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04703192?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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