TriangleNCT00261846 · OUTCOME
Area Under the Concentration-Time Curve at Steady State (AUCss) - Part 1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng*hr/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15
What was measured
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUC over 24 hours at steady state (ss), on Day 15 was calculated.
Analysis population: Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.
Groups in this outcome
Bosutinib 400 mg (Part 1)
Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
Bosutinib 500 mg (Part 1)
Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
Bosutinib 600 mg (Part 1)
Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
| Group | Source count |
|---|---|
| Bosutinib 400 mg (Part 1) | 3 |
| Bosutinib 500 mg (Part 1) | 3 |
| Bosutinib 600 mg (Part 1) | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib 400 mg (Part 1) | 2720 | 442 | Not reported | Not reported | Not reported |
| Bosutinib 500 mg (Part 1) | 3650 | 425 | Not reported | Not reported | Not reported |
| Bosutinib 600 mg (Part 1) | 3630 | 1270 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 442
- value
- 2720
- group Id
- OG001
- spread
- 425
- value
- 3650
- group Id
- OG002
- spread
- 1270
- value
- 3630
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 9
- units
- Participants
- description
- AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUC over 24 hours at steady state (ss), on Day 15 was calculated.
- dispersion Type
- Standard Deviation
- groups
- description
- Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
- id
- OG000
- title
- Bosutinib 400 mg (Part 1)
- description
- Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
- id
- OG001
- title
- Bosutinib 500 mg (Part 1)
- description
- Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
- id
- OG002
- title
- Bosutinib 600 mg (Part 1)
- param Type
- MEAN
- population Description
- Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this measure.
- reporting Status
- POSTED
- time Frame
- 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15
- title
- Area Under the Concentration-Time Curve at Steady State (AUCss) - Part 1
- type
- PRIMARY
- unit Of Measure
- ng*hr/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice