TriangleNCT01520909 · OUTCOME
Number of Participants With a Change in Visual Acuity Since Baseline at Week 12 of 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 and Week 12 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. Change in visual acuity results are presented as No (no change from Baseline), Not Clinically Significant (NCS), Improvement, and Worsening since Baseline. The Baseline value was obtained at the Screening Visit.
Analysis population: Safety Population
Groups in this outcome
EPart 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 |
|---|---|
| EPart 1 (Randomized Period)-Placebo | 29 |
| Part 1 (Randomized Period)-Eltrombopag | 63 |
Reported measurements
No Change
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EPart 1 (Randomized Period)-Placebo | 22 | Not reported | Not reported | Not reported | Not reported |
| Part 1 (Randomized Period)-Eltrombopag | 47 | Not reported | Not reported | Not reported | Not reported |
NCS
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EPart 1 (Randomized Period)-Placebo | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1 (Randomized Period)-Eltrombopag | 8 | Not reported | Not reported | Not reported | Not reported |
Improvement
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EPart 1 (Randomized Period)-Placebo | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1 (Randomized Period)-Eltrombopag | 2 | Not reported | Not reported | Not reported | Not reported |
Worsening
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EPart 1 (Randomized Period)-Placebo | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1 (Randomized Period)-Eltrombopag | 1 | Not reported | Not reported | Not reported | Not reported |
Not Measured
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| EPart 1 (Randomized Period)-Placebo | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1 (Randomized Period)-Eltrombopag | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 47
- title
- No Change
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 8
- title
- NCS
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- title
- Improvement
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- title
- Worsening
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 5
- title
- Not Measured
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 63
- 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. Change in visual acuity results are presented as No (no change from Baseline), Not Clinically Significant (NCS), Improvement, and Worsening since Baseline. The Baseline value was obtained at the Screening Visit.
- 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
- EPart 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
- NUMBER
- population Description
- Safety Population
- reporting Status
- POSTED
- time Frame
- Baseline and Week 12 of Part 1
- title
- Number of Participants With a Change in Visual Acuity Since Baseline at Week 12 of Part 1
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice