TriangleNCT03029234 · OUTCOME
Volume of Distribution at Steady State (Vss) for Carfilzomib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- liters
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycles 1 and 2, day 1 at predose, 5 minutes after the start of carfilzomib infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of infusion.
What was measured
Volume of distribution at steady-state is a pharmacokinetic parameter that relates the amount of drug in the body at steady-state to the concentration of drug in the plasma.
Analysis population: PK analyses were conducted on a subset of participants at selected sites. Results are reported for participants in the PK analysis population with available data at each time point. PK profiles with a coefficient of determination \< 0.8, percent extrapolated AUC \> 20%, or negative values for Vss were excluded from the analysis.
Groups in this outcome
Carfilzomib With Dexamethasone
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants also received 20 mg dexamethasone IV or orally on days 1, 2, 8, 9, 15, 16, 22, and 23. Participants received treatment until disease progression, unacceptable toxicity, initiation of new antimyeloma therapy, withdrawal of consent, subject noncompliance, or intercurrent illness or worsening of a chronic condition, whichever occurred first.
| Group | Source count |
|---|---|
| Carfilzomib With Dexamethasone | 22 |
Reported measurements
Cycle 1 Day 1 (20 mg/m²)
| Group | Source count |
|---|---|
| Carfilzomib With Dexamethasone | 22 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib With Dexamethasone | 35.0 | 20.2 | Not reported | Not reported | Not reported |
Cycle 2 Day 1 (27 mg/m²)
| Group | Source count |
|---|---|
| Carfilzomib With Dexamethasone | 19 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib With Dexamethasone | 27.2 | 17.4 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 20.2
- value
- 35.0
- denoms
- counts
- group Id
- OG000
- value
- 22
- units
- Participants
- title
- Cycle 1 Day 1 (20 mg/m²)
- categories
- measurements
- group Id
- OG000
- spread
- 17.4
- value
- 27.2
- denoms
- counts
- group Id
- OG000
- value
- 19
- units
- Participants
- title
- Cycle 2 Day 1 (27 mg/m²)
- denoms
- counts
- group Id
- OG000
- value
- 22
- units
- Participants
- description
- Volume of distribution at steady-state is a pharmacokinetic parameter that relates the amount of drug in the body at steady-state to the concentration of drug in the plasma.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants also received 20 mg dexamethasone IV or orally on days 1, 2, 8, 9, 15, 16, 22, and 23. Participants received treatment until disease progression, unacceptable toxicity, initiation of new antimyeloma therapy, withdrawal of consent, subject noncompliance, or intercurrent illness or worsening of a chronic condition, whichever occurred first.
- id
- OG000
- title
- Carfilzomib With Dexamethasone
- param Type
- MEAN
- population Description
- PK analyses were conducted on a subset of participants at selected sites. Results are reported for participants in the PK analysis population with available data at each time point. PK profiles with a coefficient of determination \< 0.8, percent extrapolated AUC \> 20%, or negative values for Vss were excluded from the analysis.
- reporting Status
- POSTED
- time Frame
- Cycles 1 and 2, day 1 at predose, 5 minutes after the start of carfilzomib infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of infusion.
- title
- Volume of Distribution at Steady State (Vss) for Carfilzomib
- type
- SECONDARY
- unit Of Measure
- liters
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Preserved source evidence · Not medical advice