TriangleNCT00425555 · OUTCOME
Time to Peak Concentration (Tmax) of Panobinostat
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- h (hours)
- Interval / dispersion
- Full Range
- Time frame
- Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8
What was measured
Tmax is defined as the time at which the Cmax occurs. It will be obtained from the Tmax parameter calculated by WinNonlin®. If there is no measurable Cmax in the subject's PK profile, then Tmax will be missing for that subject. Tmax will be reported in units of h.
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
All Participants
Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred.
| Group | Source count |
|---|---|
| All Participants | 139 |
Reported measurements
Day 1
| Group | Source count |
|---|---|
| All Participants | 109 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 1.5 | Not reported | 0.00 | 4.00 | Not reported |
Day 8
| Group | Source count |
|---|---|
| All Participants | 60 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Participants | 1.5 | Not reported | 0.25 | 3.50 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.00
- upper Limit
- 4.00
- value
- 1.5
- denoms
- counts
- group Id
- OG000
- value
- 109
- units
- Participants
- title
- Day 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.25
- upper Limit
- 3.50
- value
- 1.5
- denoms
- counts
- group Id
- OG000
- value
- 60
- units
- Participants
- title
- Day 8
- denoms
- counts
- group Id
- OG000
- value
- 139
- units
- Participants
- description
- Tmax is defined as the time at which the Cmax occurs. It will be obtained from the Tmax parameter calculated by WinNonlin®. If there is no measurable Cmax in the subject's PK profile, then Tmax will be missing for that subject. Tmax will be reported in units of h.
- dispersion Type
- Full Range
- groups
- description
- Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred.
- id
- OG000
- title
- All Participants
- param Type
- MEDIAN
- 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
- Time to Peak Concentration (Tmax) of Panobinostat
- type
- SECONDARY
- unit Of Measure
- h (hours)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice