TriangleNCT00908037 · OUTCOME
Percentage of Participants Who Reduced or Discontinued Baseline Concomitant Idiopathic Thrombocytopenic Purpura (ITP) Medications During the 24 Weeks of Eltrombopag Treatment During Part 1.
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 up to Week 24+ 1 day of Part 1
What was measured
The 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 1 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 in Part 1, Baseline is defined as Day 1 of Part 1. A sustained reduction is defined as reduction for 4 weeks or more. An attempted red or dis 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 1 Day 1 to the last dose of study medication + 1 day.
Analysis population: ITT Population, only those participants enrolled during Part 1 were analyzed.
Groups in this outcome
Part 1 (Dose-Finding Period) Cohort 1
Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 1 (Dose-Finding Period) Cohort 2
Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of \<27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of \>=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 1 (Dose-Finding Period) Cohort 3
Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
| Group | Source count |
|---|---|
| Part 1 (Dose-Finding Period) Cohort 1 | 5 |
| Part 1 (Dose-Finding Period) Cohort 2 | 5 |
| Part 1 (Dose-Finding Period) Cohort 3 | 5 |
Reported measurements
Taking an ITP medication at BL
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose-Finding Period) Cohort 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1 (Dose-Finding Period) Cohort 2 | 20.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1 (Dose-Finding Period) Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
Attempted red or dis
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose-Finding Period) Cohort 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1 (Dose-Finding Period) Cohort 2 | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1 (Dose-Finding Period) Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
Permanent red or dis of all BL ITP mediation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose-Finding Period) Cohort 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1 (Dose-Finding Period) Cohort 2 | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1 (Dose-Finding Period) Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
Permanent red or dis at least 1 BL ITP medcation
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose-Finding Period) Cohort 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1 (Dose-Finding Period) Cohort 2 | 100.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1 (Dose-Finding Period) Cohort 3 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 20.0
- group Id
- OG002
- value
- 0
- title
- Taking an ITP medication at BL
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 100.0
- group Id
- OG002
- value
- 0
- title
- Attempted red or dis
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 100.0
- group Id
- OG002
- value
- 0
- title
- Permanent red or dis of all BL ITP mediation
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 100.0
- group Id
- OG002
- value
- 0
- title
- Permanent red or dis at least 1 BL ITP medcation
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 5
- units
- Participants
- description
- The 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 1 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 in Part 1, Baseline is defined as Day 1 of Part 1. A sustained reduction is defined as reduction for 4 weeks or more. An attempted red or dis 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 1 Day 1 to the last dose of study medication + 1 day.
- groups
- description
- Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. 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 1 (Dose-Finding Period) Cohort 1
- description
- Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of \<27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of \>=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
- id
- OG001
- title
- Part 1 (Dose-Finding Period) Cohort 2
- description
- Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
- id
- OG002
- title
- Part 1 (Dose-Finding Period) Cohort 3
- param Type
- NUMBER
- population Description
- ITT Population, only those participants enrolled during Part 1 were analyzed.
- reporting Status
- POSTED
- time Frame
- From Baseline up to Week 24+ 1 day of Part 1
- title
- Percentage of Participants Who Reduced or Discontinued Baseline Concomitant Idiopathic Thrombocytopenic Purpura (ITP) Medications During the 24 Weeks of Eltrombopag Treatment During Part 1.
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice