TriangleNCT01308580 · OUTCOME
Plasma Clearance (CL) for Cabazitaxel
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Litre/hour
- Interval / dispersion
- Standard Deviation
- Time frame
- Day 1 of Cycle 1: 5 minutes before the end of infusion (EOI), 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI
What was measured
Blood samples for pharmacokinetic (PK) analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy.
Analysis population: Analysis was performed on PK population that included participants who had evaluable PK data. Number of participants analyzed= participants with PK assessment at specified time-points.
Groups in this outcome
Cabazitaxel 20 mg/m^2
Cabazitaxel 20 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
Cabazitaxel 25 mg/m^2
Cabazitaxel 25 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
| Group | Source count |
|---|---|
| Cabazitaxel 20 mg/m^2 | 133 |
| Cabazitaxel 25 mg/m^2 | 166 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cabazitaxel 20 mg/m^2 | 44.832 | 15.075 | Not reported | Not reported | Not reported |
| Cabazitaxel 25 mg/m^2 | 49.662 | 17.613 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 15.075
- value
- 44.832
- group Id
- OG001
- spread
- 17.613
- value
- 49.662
- denoms
- counts
- group Id
- OG000
- value
- 133
- group Id
- OG001
- value
- 166
- units
- Participants
- description
- Blood samples for pharmacokinetic (PK) analysis were obtained from a subset of the study participants (approximately 150 participants/group, by protocol) according to a sparse sampling strategy.
- dispersion Type
- Standard Deviation
- groups
- description
- Cabazitaxel 20 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
- id
- OG000
- title
- Cabazitaxel 20 mg/m^2
- description
- Cabazitaxel 25 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
- id
- OG001
- title
- Cabazitaxel 25 mg/m^2
- param Type
- MEAN
- population Description
- Analysis was performed on PK population that included participants who had evaluable PK data. Number of participants analyzed= participants with PK assessment at specified time-points.
- reporting Status
- POSTED
- time Frame
- Day 1 of Cycle 1: 5 minutes before the end of infusion (EOI), 15 minutes, 1 to 4 hour, 6 to 24 hours, 48 to 168 hour after EOI
- title
- Plasma Clearance (CL) for Cabazitaxel
- type
- SECONDARY
- unit Of Measure
- Litre/hour
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice