TriangleNCT01456039 · OUTCOME
Kaplan Meier Estimate of Duration of Response (DOR) for PTCL Responders Based on the Modified 2007 IWC as Assessed by the 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
DOR was defined as the number of days from the date of the first disease response (Complete, Unconfirmed Complete or Partial Response) until the date of progression, analyzed using Kaplan-Meier methods.
Analysis population: Intent to treat population for participants with PTCL who received at least one dose of romidepsin and achieved a PR or better (CR, CRu or PR)
Groups in this outcome
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 2: Romidepsin 14mg/m^2 | 1 |
| Phase 2: Romidepsin 14mg/m^2 | 17 |
| Total: Romidepsin 14mg/m^2 | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Cohort 2: Romidepsin 14mg/m^2 | 163.00 | Not reported | NA | NA | Not available = Not estimable due to the low number of events |
| Phase 2: Romidepsin 14mg/m^2 | 337.00 | Not reported | 60.00 | NA | Not available = Not estimable due to the low number of events |
| Total: Romidepsin 14mg/m^2 | 163.00 | Not reported | 60.00 | NA | Not available = Not estimable due to the low number of events |
Complete source fields
- classes
- categories
- measurements
- comment
- Not available = Not estimable due to the low number of events
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 163.00
- comment
- Not available = Not estimable due to the low number of events
- group Id
- OG001
- lower Limit
- 60.00
- upper Limit
- NA
- value
- 337.00
- comment
- Not available = Not estimable due to the low number of events
- group Id
- OG002
- lower Limit
- 60.00
- upper Limit
- NA
- value
- 163.00
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 17
- group Id
- OG002
- value
- 18
- units
- Participants
- description
- DOR was defined as the number of days from the date of the first disease response (Complete, Unconfirmed Complete or Partial Response) until the date of progression, analyzed using Kaplan-Meier methods.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Romidepsin 14mg/m\^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
- id
- OG000
- 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
- OG001
- 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
- OG002
- title
- Total: Romidepsin 14mg/m^2
- param Type
- MEDIAN
- population Description
- Intent to treat population for participants with PTCL who received at least one dose of romidepsin and achieved a PR or better (CR, CRu or PR)
- 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 Estimate of Duration of Response (DOR) for PTCL Responders Based on the Modified 2007 IWC as Assessed by the IER.
- type
- SECONDARY
- unit Of Measure
- days
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Preserved source evidence · Not medical advice