TriangleNCT00908037 · OUTCOME
Percentage of Participants Achieving Platelet Counts >=50Gi/L During Treatment With Eltrombopag in >= 60% of Assessments Between Day 15 and Day 43 (Weeks 2 Through 6) of the Randomized Treatment Period (Part 2)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- Not reported
- Time frame
- Between Day 15 and Day 43 of Part 2
What was measured
Sustained platelet response between the treatment groups was assessed by determining the number of participants who achieved a platelet count \>=50 Gi/L during treatment with eltrombopag in \>= 60% of assessments between Day 15 and Day 43 in the absence of rescue treatment were reported here.
Analysis population: Intent-to-Treat (ITT) Population, only those participants enrolled in Part 2 of this study were analyzed.
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 | 22 |
| Part 2 (Randomized Period) - Eltrombopag | 45 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Randomized Period) -Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2 (Randomized Period) - Eltrombopag | 35.6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 35.6
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 45
- units
- Participants
- description
- Sustained platelet response between the treatment groups was assessed by determining the number of participants who achieved a platelet count \>=50 Gi/L during treatment with eltrombopag in \>= 60% of assessments between Day 15 and Day 43 in the absence of rescue treatment were reported here.
- 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
- NUMBER
- population Description
- Intent-to-Treat (ITT) Population, only those participants enrolled in Part 2 of this study were analyzed.
- reporting Status
- POSTED
- time Frame
- Between Day 15 and Day 43 of Part 2
- title
- Percentage of Participants Achieving Platelet Counts >=50Gi/L During Treatment With Eltrombopag in >= 60% of Assessments Between Day 15 and Day 43 (Weeks 2 Through 6) of the Randomized Treatment Period (Part 2)
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice