TriangleNCT00261846 · OUTCOME
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC(0-48)] - 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, 48 hours post-dose on Day 1
What was measured
AUC(0-48)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-48).
Analysis population: Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment.
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) | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bosutinib 400 mg (Part 1) | 1850 | 710 | Not reported | Not reported | Not reported |
| Bosutinib 500 mg (Part 1) | 2060 | 483 | Not reported | Not reported | Not reported |
| Bosutinib 600 mg (Part 1) | 2340 | 1140 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 710
- value
- 1850
- group Id
- OG001
- spread
- 483
- value
- 2060
- group Id
- OG002
- spread
- 1140
- value
- 2340
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 12
- units
- Participants
- description
- AUC(0-48)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-48).
- 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.
- reporting Status
- POSTED
- time Frame
- 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1
- title
- Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC(0-48)] - Part 1
- type
- PRIMARY
- unit Of Measure
- ng*hr/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice