TriangleNCT00908037 · OUTCOME
Weighted Mean Platelet Count
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Gi/L
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline and Day 43 of Part 2
What was measured
The weighted mean platelet count is defined as the area under the platelet-time curve divided by the duration of the treatment (12 weeks). Based on the Analysis of Covariance (ANCOVA) model, the weighted mean platelet count is the sum of the Baseline count plus the age cohort plus the treatment. Baseline was defined as the platelet count taken on Day 1 or within 48 hours prior to the first dose of treatment.
Analysis population: ITT Population. Only participants during Part 2 with a value at baseline and post-baseline were considered for analysis
Groups in this outcome
Part 2 (Randomized Period) -Placebo
Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
Part 2 (Randomized Period) - Eltrombopag
Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of \<27 kg received 25 mg QD, and par with a body weight of \>=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD, and with a body weight of \>=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
| Group | Source count |
|---|---|
| Part 2 (Randomized Period) -Placebo | 21 |
| Part 2 (Randomized Period) - Eltrombopag | 43 |
Reported measurements
Baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Randomized Period) -Placebo | 12.2 | 8.59 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) - Eltrombopag | 15.5 | 8.03 | Not reported | Not reported | Not reported |
Day 43
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Randomized Period) -Placebo | 30.5 | 24.98 | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) - Eltrombopag | 68 | 56.78 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 8.59
- value
- 12.2
- group Id
- OG001
- spread
- 8.03
- value
- 15.5
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 24.98
- value
- 30.5
- group Id
- OG001
- spread
- 56.78
- value
- 68
- title
- Day 43
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 43
- units
- Participants
- description
- The weighted mean platelet count is defined as the area under the platelet-time curve divided by the duration of the treatment (12 weeks). Based on the Analysis of Covariance (ANCOVA) model, the weighted mean platelet count is the sum of the Baseline count plus the age cohort plus the treatment. Baseline was defined as the platelet count taken on Day 1 or within 48 hours prior to the first dose of treatment.
- dispersion Type
- Standard Deviation
- groups
- description
- Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
- id
- OG000
- title
- Part 2 (Randomized Period) -Placebo
- description
- Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of \<27 kg received 25 mg QD, and par with a body weight of \>=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD, and with a body weight of \>=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
- id
- OG001
- title
- Part 2 (Randomized Period) - Eltrombopag
- param Type
- MEAN
- population Description
- ITT Population. Only participants during Part 2 with a value at baseline and post-baseline were considered for analysis
- reporting Status
- POSTED
- time Frame
- Baseline and Day 43 of Part 2
- title
- Weighted Mean Platelet Count
- type
- SECONDARY
- unit Of Measure
- Gi/L
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice