TriangleNCT01456039 · OUTCOME
AUC0-t, at Steady State (ss) of Romidepsin in Phase 1 at Cycle 1, Day 15
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng*h/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Day 15 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration
What was measured
Area under the plasma concentration-time curve from time zero to the last quantifiable time point at steady state, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing
Analysis population: PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.
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.
| Group | Source count |
|---|---|
| Phase 1: Cohort 1: Romidepsin 9mg/m^2 | 3 |
| Phase 1: Cohort 2: Romidepsin 14mg/m^2 | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Cohort 1: Romidepsin 9mg/m^2 | 1024.66 | 78.1 | Not reported | Not reported | Not reported |
| Phase 1: Cohort 2: Romidepsin 14mg/m^2 | 1825.74 | 25.8 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 78.1
- value
- 1024.66
- group Id
- OG001
- spread
- 25.8
- value
- 1825.74
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- units
- Participants
- description
- Area under the plasma concentration-time curve from time zero to the last quantifiable time point at steady state, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing
- dispersion Type
- Geometric Coefficient of Variation
- 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
- param Type
- GEOMETRIC_MEAN
- population Description
- PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis.
- reporting Status
- POSTED
- time Frame
- Day 15 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration
- title
- AUC0-t, at Steady State (ss) of Romidepsin in Phase 1 at Cycle 1, Day 15
- type
- SECONDARY
- unit Of Measure
- ng*h/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice