TriangleNCT01121393 · OUTCOME
Pharmacokinetics of Afatinib at Day 29
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Day 29 (course 2, visit 2)
What was measured
Outcome data are the trough plasma concentrations of afatinib at day 29 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the PK assessment period).
Analysis population: All patients who had at least 1 afatinib dose and who had at least 1 valid afatinib plasma concentration available.
Groups in this outcome
Afatinib 30mg q.d.
Patients receiving Afatinib 30mg once daily (q.d.) after a dose reduction.
Afatinib 40mg q.d.
Patients receiving Afatinib 40mg once daily (q.d.)
Afatinib 50mg q.d.
Patients receiving Afatinib 50mg once daily (q.d.) after a dose escalation.
| Group | Source count |
|---|---|
| Afatinib 30mg q.d. | 6 |
| Afatinib 40mg q.d. | 161 |
| Afatinib 50mg q.d. | 34 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Afatinib 30mg q.d. | 19.5 | 90.3 | Not reported | Not reported | Not reported |
| Afatinib 40mg q.d. | 23.8 | 70.6 | Not reported | Not reported | Not reported |
| Afatinib 50mg q.d. | 22.8 | 60.8 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 90.3
- value
- 19.5
- group Id
- OG001
- spread
- 70.6
- value
- 23.8
- group Id
- OG002
- spread
- 60.8
- value
- 22.8
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 161
- group Id
- OG002
- value
- 34
- units
- Participants
- description
- Outcome data are the trough plasma concentrations of afatinib at day 29 after multiple daily dosing of 40mg afatinib and after dose escalation to 50mg or dose reduction to 30mg afatinib (no patient dose reduced to 20mg during the PK assessment period).
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Patients receiving Afatinib 30mg once daily (q.d.) after a dose reduction.
- id
- OG000
- title
- Afatinib 30mg q.d.
- description
- Patients receiving Afatinib 40mg once daily (q.d.)
- id
- OG001
- title
- Afatinib 40mg q.d.
- description
- Patients receiving Afatinib 50mg once daily (q.d.) after a dose escalation.
- id
- OG002
- title
- Afatinib 50mg q.d.
- param Type
- GEOMETRIC_MEAN
- population Description
- All patients who had at least 1 afatinib dose and who had at least 1 valid afatinib plasma concentration available.
- reporting Status
- POSTED
- time Frame
- Day 29 (course 2, visit 2)
- title
- Pharmacokinetics of Afatinib at Day 29
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice