Trial · NCT01456039
Results by group156
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 156
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Number of Participants With Dose-limiting Toxicity (DLT) in Accordance With National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 as Determined by the Efficacy and Safety Evaluation Committee (ESEC) | Phase 1: Cohort 1: Romidepsin 9mg/m^2 | 0 | participants | ||
Number of Participants With Dose-limiting Toxicity (DLT) in Accordance With National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 as Determined by the Efficacy and Safety Evaluation Committee (ESEC) | Phase 1: Cohort 2: Romidepsin 14mg/m^2 | 0 | participants | ||
| Percentage of PTCL Participants With an Overall Best Response in Accordance With a Modified International Workshop Response Criteria (IWC) 1999 in Phase 2 | Phase 1: Romidepsin 9mg/m^2 | 0 | 95% Confidence Interval 0.000 to 0.000 | percentage of participants | |
| Percentage of PTCL Participants With an Overall Best Response in Accordance With a Modified International Workshop Response Criteria (IWC) 1999 in Phase 2 | Phase 1: Romidepsin 14mg/m^2 | 66.7 | 95% Confidence Interval 28.947 to 100.000 | percentage of participants | |
| Percentage of PTCL Participants With an Overall Best Response in Accordance With a Modified International Workshop Response Criteria (IWC) 1999 in Phase 2 | Phase 2: Romidepsin 14mg/m^2 | 42.5 | 95% Confidence Interval 27.180 to 57.820 | percentage of participants | |
| Percentage of PTCL Participants With an Overall Best Response in Accordance With a Modified International Workshop Response Criteria (IWC) 1999 in Phase 2 | Total: Romidepsin 14mg/m^2 | 45.7 | 95% Confidence Interval 31.258 to 60.046 | percentage of participants | |
| Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin | Phase 1: Romidepsin 9mg/m^2 | Any 1 TEAE | 3 | participants | |
| Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin | Phase 1: Romidepsin 14mg/m^2 | Any 1 TEAE | 7 | participants | |
| Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin | Phase 2: Romidepsin 14mg/m^2 | Any 1 TEAE | 40 | participants | |
| Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin | Total: Romidepsin 14mg/m^2 | Any 1 TEAE | 47 | participants | |
| Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin | Phase 1: Romidepsin 9mg/m^2 | TEAE related to any study drug | 3 | participants | |
| Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin | Phase 1: Romidepsin 14mg/m^2 | TEAE related to any study drug | 7 | participants | |
| Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin | Phase 2: Romidepsin 14mg/m^2 | TEAE related to any study drug | 40 | participants | |
| Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin | Total: Romidepsin 14mg/m^2 | TEAE related to any study drug | 47 | participants | |
| Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin | Phase 1: Romidepsin 9mg/m^2 | TEAE with CTCAE Grade 3 or greater | 3 | participants | |
| Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin | Phase 1: Romidepsin 14mg/m^2 | TEAE with CTCAE Grade 3 or greater | 6 | participants | |
| Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin | Phase 2: Romidepsin 14mg/m^2 | TEAE with CTCAE Grade 3 or greater | 37 | participants | |
| Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin | Total: Romidepsin 14mg/m^2 | TEAE with CTCAE Grade 3 or greater | 43 | participants | |
| Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin | Phase 1: Romidepsin 9mg/m^2 | TEAE with CTCAE ≥Grade 3 related to study drug | 3 | participants | |
| Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin | Phase 1: Romidepsin 14mg/m^2 | TEAE with CTCAE ≥Grade 3 related to study drug | 6 | participants |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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