TriangleNCT00106431 · OUTCOME
Duration of Objective Disease Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- Up to 10 months; median duration of follow up was 5.1 months
What was measured
Duration of Objective Response was defined as the number of months from the date of the first disease response (clinical complete response \[CCR\], or partial response \[PR\]) (later confirmed) until the date of progression and was determined using Kaplan-Meier product-limit estimates. In this analysis, pts who did not progress were censored as of their last evaluation with an OPDREC assessment.
Analysis population: Efficacy analysis based on interim analysis of data for as treated population
Groups in this outcome
Romidepsin
Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
| Group | Source count |
|---|---|
| Romidepsin | 96 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Romidepsin | 14.91 | Not reported | 0.03 | 19.81 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.03
- upper Limit
- 19.81
- value
- 14.91
- denoms
- counts
- group Id
- OG000
- value
- 96
- units
- Participants
- description
- Duration of Objective Response was defined as the number of months from the date of the first disease response (clinical complete response \[CCR\], or partial response \[PR\]) (later confirmed) until the date of progression and was determined using Kaplan-Meier product-limit estimates. In this analysis, pts who did not progress were censored as of their last evaluation with an OPDREC assessment.
- dispersion Type
- Full Range
- groups
- description
- Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
- id
- OG000
- title
- Romidepsin
- param Type
- MEDIAN
- population Description
- Efficacy analysis based on interim analysis of data for as treated population
- reporting Status
- POSTED
- time Frame
- Up to 10 months; median duration of follow up was 5.1 months
- title
- Duration of Objective Disease Response
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice