TriangleNCT01456039 · OUTCOME
Kaplan Meier (K-M) Estimate of Time to Progression (TTP) in PTCL Participants Based on the Modified 2007 IWC as Assessed by IER
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Median follow-up time was 100 days; up to the data cut-off of 28 July 2015
What was measured
Time to progression (≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions) was defined as the duration from the date of the first study drug dose to the date of relapse or progression
Analysis population: ITT includes all participants who received at least one dose of romidepsin
Groups in this outcome
Phase 1: Cohort 1: Romidepsin 9mg/m^2
Romidepsin 9mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
Phase 1: Cohort 2: Romidepsin 14mg/m^2
Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
Phase 2: Romidepsin 14mg/m^2
Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
Total: Romidepsin 14mg/m^2
Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
| Group | Source count |
|---|---|
| Phase 1: Cohort 1: Romidepsin 9mg/m^2 | 2 |
| Phase 1: Cohort 2: Romidepsin 14mg/m^2 | 6 |
| Phase 2: Romidepsin 14mg/m^2 | 40 |
| Total: Romidepsin 14mg/m^2 | 46 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Cohort 1: Romidepsin 9mg/m^2 | NA | Not reported | NA | NA | Median time to progression based on K-M estimate had not been reached |
| Phase 1: Cohort 2: Romidepsin 14mg/m^2 | 899.00 | Not reported | NA | NA | Not estimable due to low number of events |
| Phase 2: Romidepsin 14mg/m^2 | 179.00 | Not reported | 96.00 | 392.00 | Not reported |
| Total: Romidepsin 14mg/m^2 | 179.00 | Not reported | 96.00 | 392.00 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Median time to progression based on K-M estimate had not been reached
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Not estimable due to low number of events
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 899.00
- group Id
- OG002
- lower Limit
- 96.00
- upper Limit
- 392.00
- value
- 179.00
- group Id
- OG003
- lower Limit
- 96.00
- upper Limit
- 392.00
- value
- 179.00
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 40
- group Id
- OG003
- value
- 46
- units
- Participants
- description
- Time to progression (≥50% increase from the nadir in the individual sum of the products of the diameters of any index lesion; the reappearance of pathology, enlargement of liver/spleen, or unequivocal progression of non-measurable disease or appearance of any new lesions) was defined as the duration from the date of the first study drug dose to the date of relapse or progression
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Romidepsin 9mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
- id
- OG000
- title
- Phase 1: Cohort 1: Romidepsin 9mg/m^2
- description
- Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
- id
- OG001
- title
- Phase 1: Cohort 2: Romidepsin 14mg/m^2
- description
- Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
- id
- OG002
- title
- Phase 2: Romidepsin 14mg/m^2
- description
- Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
- id
- OG003
- title
- Total: Romidepsin 14mg/m^2
- param Type
- MEDIAN
- population Description
- ITT includes all participants who received at least one dose of romidepsin
- reporting Status
- POSTED
- time Frame
- Median follow-up time was 100 days; up to the data cut-off of 28 July 2015
- title
- Kaplan Meier (K-M) Estimate of Time to Progression (TTP) in PTCL Participants Based on the Modified 2007 IWC as Assessed by IER
- type
- SECONDARY
- unit Of Measure
- days
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Preserved source evidence · Not medical advice