TriangleNCT00908037 · OUTCOME
Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1
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
- Baseline, 3and 6-mo Follow-up of Part 1
What was measured
The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. The number of participants with a change in visual acuity and worsening visual acuity due to cataracts since Baseline are presented for Part 1 Follow-up Visits at 3-months (FU3) and at 6-months (FU6). Change in visual acuity since Baseline is displayed under the left eye but applies to both eyes. Change in visual acuity (VA) is categorized as "yes" or "no". Change due to cataracts is categorized as "yes" or "no".
Analysis population: Safety Population: all subjects who have received at least one dose of the investigational product 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 12.5 mg 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
Change in VA at FU3, no
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose-Finding Period) Cohort 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1 (Dose-Finding Period) Cohort 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1 (Dose-Finding Period) Cohort 3 | 2 | Not reported | Not reported | Not reported | Not reported |
Change in VA at FU3, yes
| 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 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1 (Dose-Finding Period) Cohort 3 | 1 | Not reported | Not reported | Not reported | Not reported |
Change in VA at FU6, no
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 (Dose-Finding Period) Cohort 1 | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1 (Dose-Finding Period) Cohort 2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1 (Dose-Finding Period) Cohort 3 | 5 | Not reported | Not reported | Not reported | Not reported |
Change in VA at FU6, yes
| 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 | 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 |
Change due to cataracts at FU3, no
| 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 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1 (Dose-Finding Period) Cohort 3 | 1 | Not reported | Not reported | Not reported | Not reported |
Change due to cataracts at FU3, yes
| 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 | 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 |
Change due to cataracts at FU6, no
| 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 | 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 |
Change due to cataracts at FU6, yes
| 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 | 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
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- title
- Change in VA at FU3, no
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- Change in VA at FU3, yes
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- title
- Change in VA at FU6, no
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Change in VA at FU6, yes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- title
- Change due to cataracts at FU3, no
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Change due to cataracts at FU3, yes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Change due to cataracts at FU6, no
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Change due to cataracts at FU6, yes
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 5
- units
- Participants
- description
- The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. The number of participants with a change in visual acuity and worsening visual acuity due to cataracts since Baseline are presented for Part 1 Follow-up Visits at 3-months (FU3) and at 6-months (FU6). Change in visual acuity since Baseline is displayed under the left eye but applies to both eyes. Change in visual acuity (VA) is categorized as "yes" or "no". Change due to cataracts is categorized as "yes" or "no".
- 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 12.5 mg 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
- Safety Population: all subjects who have received at least one dose of the investigational product during Part 1 were analyzed.
- reporting Status
- POSTED
- time Frame
- Baseline, 3and 6-mo Follow-up of Part 1
- title
- Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice