TriangleNCT00445068 · OUTCOME
Maximum Plasma Concentration (Cmax) of Panobinostat
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
- Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
What was measured
Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations. It will be obtained from the Cmax parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Cmax will be missing for that subject. Cmax will be reported in units of ng/mL.
Analysis population: The analysis was performed in PAS population, defined as all participants who provide at least one post-dose PK plasma sample. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.
Groups in this outcome
Panobinostat
Participants received panobinostat 20 mg orally OD, three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle. Participants could continue treatment until disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Panobinostat | 27 |
Reported measurements
Day 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Panobinostat | 7.6 | 5.52 | Not reported | Not reported | Not reported |
Day 8
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Panobinostat | 9.7 | 6.51 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 5.52
- value
- 7.6
- title
- Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 6.51
- value
- 9.7
- title
- Day 8
- denoms
- counts
- group Id
- OG000
- value
- 27
- units
- Participants
- description
- Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations. It will be obtained from the Cmax parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Cmax will be missing for that subject. Cmax will be reported in units of ng/mL.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received panobinostat 20 mg orally OD, three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle. Participants could continue treatment until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Panobinostat
- param Type
- MEAN
- population Description
- The analysis was performed in PAS population, defined as all participants who provide at least one post-dose PK plasma sample. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.
- reporting Status
- POSTED
- time Frame
- Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
- title
- Maximum Plasma Concentration (Cmax) of Panobinostat
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice