TriangleNCT03245450 · OUTCOME
Volume of Distribution Estimates From the Population PK Model for Eribulin
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- liter
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Cycle 1 Day 1: 0.5-120 hours after eribulin infusion; Cycle 1 Day 8: pre-dose and at the end of the eribulin infusion (cycle length=21 days)
What was measured
Per the planned PK analysis, PK samples were collected and analyzed using a population PK approach to estimate PK parameters. Eribulin plasma concentration data from this study were pooled from studies (NCT00069264, NCT00069277, NCT00326950, NCT00706095, NCT01000376, NCT01106248, NCT02171260, NCT00413192, NCT01458249, NCT03441360 and NCT01327885), and a population PK model was applied to the pooled dataset. Data presented are the volume of distribution of the central compartment (V1), volume of distribution of the first peripheral compartment (V2), and volume of distribution of the second peripheral compartment (V3) parameter estimates with Measure Type "Number" defining the eribulin PK model. They are population PK model predictions and have been estimated using non-linear mixed effects model.
Analysis population: PK analysis set included all participants who had documented dosing history had at least one postdosing quantifiable drug concentration. Analysis population for this outcome measure included participants from current study E7389-G000-213 and from studies (NCT00069264,NCT00069277,NCT00326950,NCT00706095,NCT01000376,NCT01106248,NCT02171260, NCT00413192,NCT01458249,NCT03441360,NCT01327885)."Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Groups in this outcome
Eribulin Mesilate - All Participants
All participants who received eribulin mesilate intravenous infusion over the dose range 0.25 to 4.0 mg/m\^2 in current study (E7389-G000-213) and in studies (NCT00069264, NCT00069277, NCT00326950, NCT00706095, NCT01000376, NCT01106248, NCT02171260, NCT00413192, NCT01458249, NCT03441360 and NCT01327885).
| Group | Source count |
|---|---|
| Eribulin Mesilate - All Participants | 561 |
Reported measurements
V1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Eribulin Mesilate - All Participants | 4.08 | Not reported | 3.87 | 4.29 | Not reported |
V2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Eribulin Mesilate - All Participants | 2.03 | Not reported | 1.79 | 2.27 | Not reported |
V3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Eribulin Mesilate - All Participants | 106 | Not reported | 101 | 111 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.87
- upper Limit
- 4.29
- value
- 4.08
- title
- V1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.79
- upper Limit
- 2.27
- value
- 2.03
- title
- V2
- categories
- measurements
- group Id
- OG000
- lower Limit
- 101
- upper Limit
- 111
- value
- 106
- title
- V3
- denoms
- counts
- group Id
- OG000
- value
- 561
- units
- Participants
- description
- Per the planned PK analysis, PK samples were collected and analyzed using a population PK approach to estimate PK parameters. Eribulin plasma concentration data from this study were pooled from studies (NCT00069264, NCT00069277, NCT00326950, NCT00706095, NCT01000376, NCT01106248, NCT02171260, NCT00413192, NCT01458249, NCT03441360 and NCT01327885), and a population PK model was applied to the pooled dataset. Data presented are the volume of distribution of the central compartment (V1), volume of distribution of the first peripheral compartment (V2), and volume of distribution of the second peripheral compartment (V3) parameter estimates with Measure Type "Number" defining the eribulin PK model. They are population PK model predictions and have been estimated using non-linear mixed effects model.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- All participants who received eribulin mesilate intravenous infusion over the dose range 0.25 to 4.0 mg/m\^2 in current study (E7389-G000-213) and in studies (NCT00069264, NCT00069277, NCT00326950, NCT00706095, NCT01000376, NCT01106248, NCT02171260, NCT00413192, NCT01458249, NCT03441360 and NCT01327885).
- id
- OG000
- title
- Eribulin Mesilate - All Participants
- param Type
- NUMBER
- population Description
- PK analysis set included all participants who had documented dosing history had at least one postdosing quantifiable drug concentration. Analysis population for this outcome measure included participants from current study E7389-G000-213 and from studies (NCT00069264,NCT00069277,NCT00326950,NCT00706095,NCT01000376,NCT01106248,NCT02171260, NCT00413192,NCT01458249,NCT03441360,NCT01327885)."Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1: 0.5-120 hours after eribulin infusion; Cycle 1 Day 8: pre-dose and at the end of the eribulin infusion (cycle length=21 days)
- title
- Volume of Distribution Estimates From the Population PK Model for Eribulin
- type
- SECONDARY
- unit Of Measure
- liter
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Preserved source evidence · Not medical advice