TriangleNCT01520909 · 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 Week 12 of Part 1
What was measured
The weighted mean platelet count is defined as "the area under the platelet-time curve divided by the duration of the study (12 weeks)". Weighted mean platelet counts from baseline to week 12 of the randomized period was compared between placebo and eltrombopag using an analysis of covariance model (ANCOVA) adjusting for baseline platelet count and age cohort. For each subject the area between two adjacent visits with platelet counts was calculated. The area was calculated for all pairs of adjacent visits starting at Day 1 of randomized period and then the total sum of all the areas was divided by the total duration of time during the randomized period. For each subject, this method calculates an 'average' platelet count and it allows the possibility that subjects may have had different number of assessments during different times relative to baseline.
Analysis population: ITT Population. Only those participants with a value at Baseline and post-Baseline were analyzed.
Groups in this outcome
Part 1 (Randomized Period)-Placebo
In Part 1, participants aged between 6 and 17 years with a body weight \<27 kg received placebo 37.5 mg QD, and those with a body weight \>=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
Part 1 (Randomized Period) - Eltrombopag
In Part 1, participants aged between 6 and 17 years with a 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. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
| Group | Source count |
|---|---|
| Part 1 (Randomized Period)-Placebo | 29 |
| Part 1 (Randomized Period) - Eltrombopag | 62 |
Reported measurements
Baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Randomized Period)-Placebo | 14.2 | 8.01 | Not reported | Not reported | Not reported |
| Part 1 (Randomized Period) - Eltrombopag | 14.0 | 8.09 | Not reported | Not reported | Not reported |
Week 12
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Randomized Period)-Placebo | 23.7 | 19.56 | Not reported | Not reported | Not reported |
| Part 1 (Randomized Period) - Eltrombopag | 63.9 | 46.68 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 8.01
- value
- 14.2
- group Id
- OG001
- spread
- 8.09
- value
- 14.0
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 19.56
- value
- 23.7
- group Id
- OG001
- spread
- 46.68
- value
- 63.9
- title
- Week 12
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 62
- units
- Participants
- description
- The weighted mean platelet count is defined as "the area under the platelet-time curve divided by the duration of the study (12 weeks)". Weighted mean platelet counts from baseline to week 12 of the randomized period was compared between placebo and eltrombopag using an analysis of covariance model (ANCOVA) adjusting for baseline platelet count and age cohort. For each subject the area between two adjacent visits with platelet counts was calculated. The area was calculated for all pairs of adjacent visits starting at Day 1 of randomized period and then the total sum of all the areas was divided by the total duration of time during the randomized period. For each subject, this method calculates an 'average' platelet count and it allows the possibility that subjects may have had different number of assessments during different times relative to baseline.
- dispersion Type
- Standard Deviation
- groups
- description
- In Part 1, participants aged between 6 and 17 years with a body weight \<27 kg received placebo 37.5 mg QD, and those with a body weight \>=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
- id
- OG000
- title
- Part 1 (Randomized Period)-Placebo
- description
- In Part 1, participants aged between 6 and 17 years with a 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. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
- id
- OG001
- title
- Part 1 (Randomized Period) - Eltrombopag
- param Type
- MEAN
- population Description
- ITT Population. Only those participants with a value at Baseline and post-Baseline were analyzed.
- reporting Status
- POSTED
- time Frame
- Baseline and Week 12 of Part 1
- 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