TriangleNCT00908037 · OUTCOME
Number of Participants Who Required a Protocol-defined Rescue 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
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From Baseline to the end of treatment up to Week 31 + 1 day of Part2/3
What was measured
Rescue treatment was defined as either a new immune (idiopathic) thrombocytopenic purpura (ITP) medication, an increase in the dose of a concomitant ITP medication from Baseline, a platelet transfusion, or a splenectomy. For particpants randomized to placebo in Part 2, Baseline is defined as Week 7 of Part 2. For participants randomized to eltrombopag in Part 2, Baseline is defined as Day 1 of Part 2. Participants randmoized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.
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
New ITP Medication
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2/3 (Eltrombopag Open-Label Period) Cohort 1 | 8 | Not reported | Not reported | Not reported | Not reported |
| Part 2/3 (Eltrombopag Open-Label Period) Cohort 2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 2/3 (Eltrombopag Open-Label Period) Cohort 3 | 4 | Not reported | Not reported | Not reported | Not reported |
Increase concomitant ITP medication from Baseline
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2/3 (Eltrombopag Open-Label Period) Cohort 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2/3 (Eltrombopag Open-Label Period) Cohort 2 | 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 |
Platelet transfusion
| 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 | 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 |
Splenectomy
| 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 | 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
- 8
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 4
- title
- New ITP Medication
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Increase concomitant ITP medication from Baseline
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Platelet transfusion
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Splenectomy
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 28
- group Id
- OG002
- value
- 15
- units
- Participants
- description
- Rescue treatment was defined as either a new immune (idiopathic) thrombocytopenic purpura (ITP) medication, an increase in the dose of a concomitant ITP medication from Baseline, a platelet transfusion, or a splenectomy. For particpants randomized to placebo in Part 2, Baseline is defined as Week 7 of Part 2. For participants randomized to eltrombopag in Part 2, Baseline is defined as Day 1 of Part 2. Participants randmoized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.
- 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 Part2/3
- title
- Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2/3
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice