TriangleNCT00908037 · OUTCOME
Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3
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
- From Baseline to the end of treatment up to Week 31 + 1 day of Part 2/3
What was measured
Participants who discontinued (dis) or had a sustained reduction (red) of a Baseline (BL) ITP medication for at least one day during the period of Day 1 of Part 2/3 to the last dose of study medication +1 day are reported. The denominator is the number of subjects taking an ITP medication at baseline. For participants randomized to placebo in Part 2, BL is defined as Week 7 of Part 2. For participants randomized to eltrombopag in Part 2, BL is defined as Day 1 of Part 2. A sustained reduction is defined as reduction for 4 weeks or more. An attempted reduction or discontinuation is a decrease in the dose or frequency from the BL dose or frequency of an ITP medication for at least one day during the period Part 2/3 Day 1 to the last dose of study medication + 1 day.
Analysis population: ITT Population, only those participants enrolled during Part 2/3 were analyzed.
Groups in this outcome
Part 2/3 (Eltrombopag Open-Label Period) Cohort 1
All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2/3 (Eltrombopag Open-Label Period) Cohort 2
All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of \<=27 kg received 25 mg QD and participants with a body weight of \>=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2/3 (Eltrombopag Open-Label Period) Cohort 3
All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
| Group | Source count |
|---|---|
| Part 2/3 (Eltrombopag Open-Label Period) Cohort 1 | 24 |
| Part 2/3 (Eltrombopag Open-Label Period) Cohort 2 | 28 |
| Part 2/3 (Eltrombopag Open-Label Period) Cohort 3 | 15 |
Reported measurements
Taking an ITP medication at BL
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2/3 (Eltrombopag Open-Label Period) Cohort 1 | 25.0 | Not reported | Not reported | Not reported | Not reported |
| Part 2/3 (Eltrombopag Open-Label Period) Cohort 2 | 17.9 | Not reported | Not reported | Not reported | Not reported |
| Part 2/3 (Eltrombopag Open-Label Period) Cohort 3 | 13.3 | Not reported | Not reported | Not reported | Not reported |
Attempted red or dis
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2/3 (Eltrombopag Open-Label Period) Cohort 1 | 66.7 | Not reported | Not reported | Not reported | Not reported |
| Part 2/3 (Eltrombopag Open-Label Period) Cohort 2 | 20.0 | Not reported | Not reported | Not reported | Not reported |
| Part 2/3 (Eltrombopag Open-Label Period) Cohort 3 | 100.0 | Not reported | Not reported | Not reported | Not reported |
Permanent (perm) dis of all BL ITP medication(med)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2/3 (Eltrombopag Open-Label Period) Cohort 1 | 16.7 | Not reported | Not reported | Not reported | Not reported |
| Part 2/3 (Eltrombopag Open-Label Period) Cohort 2 | 20.0 | Not reported | Not reported | Not reported | Not reported |
| Part 2/3 (Eltrombopag Open-Label Period) Cohort 3 | 50.0 | Not reported | Not reported | Not reported | Not reported |
Perm dis at least 1 BL ITP med
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2/3 (Eltrombopag Open-Label Period) Cohort 1 | 33.3 | Not reported | Not reported | Not reported | Not reported |
| Part 2/3 (Eltrombopag Open-Label Period) Cohort 2 | 20.0 | Not reported | Not reported | Not reported | Not reported |
| Part 2/3 (Eltrombopag Open-Label Period) Cohort 3 | 50.0 | Not reported | Not reported | Not reported | Not reported |
Perm dis all BL ITP med taken prior to Part 2/3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2/3 (Eltrombopag Open-Label Period) Cohort 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2/3 (Eltrombopag Open-Label Period) Cohort 2 | 40.0 | Not reported | Not reported | Not reported | Not reported |
| Part 2/3 (Eltrombopag Open-Label Period) Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 25.0
- group Id
- OG001
- value
- 17.9
- group Id
- OG002
- value
- 13.3
- title
- Taking an ITP medication at BL
- categories
- measurements
- group Id
- OG000
- value
- 66.7
- group Id
- OG001
- value
- 20.0
- group Id
- OG002
- value
- 100.0
- title
- Attempted red or dis
- categories
- measurements
- group Id
- OG000
- value
- 16.7
- group Id
- OG001
- value
- 20.0
- group Id
- OG002
- value
- 50.0
- title
- Permanent (perm) dis of all BL ITP medication(med)
- categories
- measurements
- group Id
- OG000
- value
- 33.3
- group Id
- OG001
- value
- 20.0
- group Id
- OG002
- value
- 50.0
- title
- Perm dis at least 1 BL ITP med
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 40.0
- group Id
- OG002
- value
- 0
- title
- Perm dis all BL ITP med taken prior to Part 2/3
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 28
- group Id
- OG002
- value
- 15
- units
- Participants
- description
- Participants who discontinued (dis) or had a sustained reduction (red) of a Baseline (BL) ITP medication for at least one day during the period of Day 1 of Part 2/3 to the last dose of study medication +1 day are reported. The denominator is the number of subjects taking an ITP medication at baseline. For participants randomized to placebo in Part 2, BL is defined as Week 7 of Part 2. For participants randomized to eltrombopag in Part 2, BL is defined as Day 1 of Part 2. A sustained reduction is defined as reduction for 4 weeks or more. An attempted reduction or discontinuation is a decrease in the dose or frequency from the BL dose or frequency of an ITP medication for at least one day during the period Part 2/3 Day 1 to the last dose of study medication + 1 day.
- groups
- description
- All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
- id
- OG000
- title
- Part 2/3 (Eltrombopag Open-Label Period) Cohort 1
- description
- All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of \<=27 kg received 25 mg QD and participants with a body weight of \>=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
- id
- OG001
- title
- Part 2/3 (Eltrombopag Open-Label Period) Cohort 2
- description
- All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
- id
- OG002
- title
- Part 2/3 (Eltrombopag Open-Label Period) Cohort 3
- param Type
- NUMBER
- population Description
- ITT Population, only those participants enrolled during Part 2/3 were analyzed.
- reporting Status
- POSTED
- time Frame
- From Baseline to the end of treatment up to Week 31 + 1 day of Part 2/3
- title
- Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice