TriangleNCT01774721 · OUTCOME
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Dacomitinib and Its Metabolite PF-05199265
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hour
- Interval / dispersion
- Full Range
- Time frame
- Pre-dose and 2, 4, 6, 8, and 24 hours post-dose (sample collection time points had window of +/- 10% of nominal time) on Cycle 2 Day 1 (Day 29)
What was measured
Tmax was defined as time to first occurrence of Cmax and can be observed directly from data as time of first occurrence.
Analysis population: PK analysis set included all participants who were treated with dacomitinib with at least 1 measured plasma concentration and were dose-compliant (who received 45 mg dacomitinib daily without interruptions/dose reductions for at least 14 days prior to day of data collection). This outcome measure was planned to be analyzed in Chinese subgroup only.
Groups in this outcome
Dacomitinib
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
| Group | Source count |
|---|---|
| Dacomitinib | 19 |
Reported measurements
Dacomitinib
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dacomitinib | 4.03 | Not reported | 2.0 | 24.0 | Not reported |
PF-05199265
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dacomitinib | 6.0 | Not reported | 0.0 | 25.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.0
- upper Limit
- 24.0
- value
- 4.03
- title
- Dacomitinib
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.0
- upper Limit
- 25.0
- value
- 6.0
- title
- PF-05199265
- denoms
- counts
- group Id
- OG000
- value
- 19
- units
- Participants
- description
- Tmax was defined as time to first occurrence of Cmax and can be observed directly from data as time of first occurrence.
- dispersion Type
- Full Range
- groups
- description
- Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
- id
- OG000
- title
- Dacomitinib
- param Type
- MEDIAN
- population Description
- PK analysis set included all participants who were treated with dacomitinib with at least 1 measured plasma concentration and were dose-compliant (who received 45 mg dacomitinib daily without interruptions/dose reductions for at least 14 days prior to day of data collection). This outcome measure was planned to be analyzed in Chinese subgroup only.
- reporting Status
- POSTED
- time Frame
- Pre-dose and 2, 4, 6, 8, and 24 hours post-dose (sample collection time points had window of +/- 10% of nominal time) on Cycle 2 Day 1 (Day 29)
- title
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of Dacomitinib and Its Metabolite PF-05199265
- type
- SECONDARY
- unit Of Measure
- hour
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice