TriangleNCT00261846 · OUTCOME
Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hours (hrs)
- Interval / dispersion
- Full Range
- Time frame
- 0 (pre-dose), 1, 2, 3, 4, 6, 8, 24, 48 hours post-dose on Day 1
Analysis population: Evaluable population included all enrolled participants who received at least one 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) | 4.00 | Not reported | 3.33 | 48.08 | Not reported |
| Bosutinib 500 mg (Part 1) | 6.00 | Not reported | 6.00 | 6.00 | Not reported |
| Bosutinib 600 mg (Part 1) | 4.00 | Not reported | 2.17 | 49.33 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.33
- upper Limit
- 48.08
- value
- 4.00
- group Id
- OG001
- lower Limit
- 6.00
- upper Limit
- 6.00
- value
- 6.00
- group Id
- OG002
- lower Limit
- 2.17
- upper Limit
- 49.33
- value
- 4.00
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 12
- units
- Participants
- dispersion Type
- Full Range
- 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
- MEDIAN
- population Description
- Evaluable population included all enrolled participants who received at least one 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
- Time to Reach Maximum Observed Plasma Concentration (Tmax) - Part 1
- type
- PRIMARY
- unit Of Measure
- hours (hrs)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice