TriangleNCT01520909 · OUTCOME
Pharmacokinetic (PK) Assessments for Eltrombopag for Cmax
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- micrograms per milliliter (ug/mL)
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)
What was measured
Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. Cmax is defined as the maximum observed concentration. The Cmax for a 50mg dose was estimated for each cohort. From the final model, a single value of each PK parameter was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.
Analysis population: PK Population. Only those participants who provided pharmacokinetic samples were analyzed
Groups in this outcome
Eltrombopag Cohort 1 (12-17 Years)
Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight \<27 kg received eltrombopag 37.5 mg QD, and those with a body weight \>=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
Eltrombopag Cohort 2 (6-11 Years)
Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight \<27 kg received eltrombopag 37.5 mg QD, and those with a body weight \>=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
Eltrombopag Cohort 3 (1-5 Years)
Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
| Group | Source count |
|---|---|
| Eltrombopag Cohort 1 (12-17 Years) | 33 |
| Eltrombopag Cohort 2 (6-11 Years) | 38 |
| Eltrombopag Cohort 3 (1-5 Years) | 19 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Eltrombopag Cohort 1 (12-17 Years) | 6.94 | Not reported | 5.96 | 8.08 | Not reported |
| Eltrombopag Cohort 2 (6-11 Years) | 11.2 | Not reported | 9.91 | 12.8 | Not reported |
| Eltrombopag Cohort 3 (1-5 Years) | 12.5 | Not reported | 10.7 | 14.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.96
- upper Limit
- 8.08
- value
- 6.94
- group Id
- OG001
- lower Limit
- 9.91
- upper Limit
- 12.8
- value
- 11.2
- group Id
- OG002
- lower Limit
- 10.7
- upper Limit
- 14.6
- value
- 12.5
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 38
- group Id
- OG002
- value
- 19
- units
- Participants
- description
- Single PK samples were collected at each visit during Part 1 Weeks 2, 4, 6, 8, 10, 12 and at each weekly or monthly visit during Part 2 Weeks 1-12 (Study Weeks 13-37). The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. Cmax is defined as the maximum observed concentration. The Cmax for a 50mg dose was estimated for each cohort. From the final model, a single value of each PK parameter was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight \<27 kg received eltrombopag 37.5 mg QD, and those with a body weight \>=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
- id
- OG000
- title
- Eltrombopag Cohort 1 (12-17 Years)
- description
- Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight \<27 kg received eltrombopag 37.5 mg QD, and those with a body weight \>=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
- id
- OG001
- title
- Eltrombopag Cohort 2 (6-11 Years)
- description
- Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
- id
- OG002
- title
- Eltrombopag Cohort 3 (1-5 Years)
- param Type
- GEOMETRIC_MEAN
- population Description
- PK Population. Only those participants who provided pharmacokinetic samples were analyzed
- reporting Status
- POSTED
- time Frame
- Part 1 Weeks 2, 4, 6, 8, 10, 12, and Part 2 Weeks 1-12 (Study Weeks 13 - 37)
- title
- Pharmacokinetic (PK) Assessments for Eltrombopag for Cmax
- type
- SECONDARY
- unit Of Measure
- micrograms per milliliter (ug/mL)
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Preserved source evidence · Not medical advice