TriangleNCT00510068 · OUTCOME
Evaluation of Pharmacokinetics (PK) Parameters: Cmax, Cmin
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Day 1 of every cycle (28 days/cycle) throughout the study
What was measured
The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. The PK parameter: maximum (peak) drug concentration (Cmax) and minimum (trough) drug concentration (Cmin).
Analysis population: The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment.
Groups in this outcome
Everolimus 10 mg/Day
Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
Everolimus 5 mg/Day
Participants received 5 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
| Group | Source count |
|---|---|
| Everolimus 10 mg/Day | 7 |
| Everolimus 5 mg/Day | 1 |
Reported measurements
Cmax
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus 10 mg/Day | 62.4 | 18.5 | Not reported | Not reported | Not reported |
| Everolimus 5 mg/Day | 27.4 | NA | Not reported | Not reported | Summary statistics will only be produced if the sample size for the dose group in the respective cycle is 3 or more. |
Cmin
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Everolimus 10 mg/Day | 9.80 | 4.95 | Not reported | Not reported | Not reported |
| Everolimus 5 mg/Day | 12.2 | NA | Not reported | Not reported | Summary statistics will only be produced if the sample size for the dose group in the respective cycle is 3 or more. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 18.5
- value
- 62.4
- comment
- Summary statistics will only be produced if the sample size for the dose group in the respective cycle is 3 or more.
- group Id
- OG001
- spread
- NA
- value
- 27.4
- title
- Cmax
- categories
- measurements
- group Id
- OG000
- spread
- 4.95
- value
- 9.80
- comment
- Summary statistics will only be produced if the sample size for the dose group in the respective cycle is 3 or more.
- group Id
- OG001
- spread
- NA
- value
- 12.2
- title
- Cmin
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 1
- units
- Participants
- description
- The PK parameters for a full PK profile at steady-state were determined in blood using non compartmental methods. The PK parameter: maximum (peak) drug concentration (Cmax) and minimum (trough) drug concentration (Cmin).
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
- id
- OG000
- title
- Everolimus 10 mg/Day
- description
- Participants received 5 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
- id
- OG001
- title
- Everolimus 5 mg/Day
- param Type
- MEAN
- population Description
- The Safety Set consisted of all patients who received any study drug and had at least one postbaseline safety assessment.
- reporting Status
- POSTED
- time Frame
- Day 1 of every cycle (28 days/cycle) throughout the study
- title
- Evaluation of Pharmacokinetics (PK) Parameters: Cmax, Cmin
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice