TriangleNCT01520909 · OUTCOME
Number of Participants With Worsening Visual Acuity Due to Cataracts at Follow-Up Week 24
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 Follow-Up Week 24 (Week 61)
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 worsening visual acuity due to cataracts at Follow-up Week 24 are presented. Change due to cataracts is categorized as "Yes" or "No."
Analysis population: Safety Population. Only those participants who had worsening visual acuity at Week 61 were analyzed.
Groups in this outcome
Part 2 (Open-Label Period) - Eltrombopag
Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: 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 and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
| Group | Source count |
|---|---|
| Part 2 (Open-Label Period) - Eltrombopag | 2 |
Reported measurements
Yes
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Open-Label Period) - Eltrombopag | 0 | Not reported | Not reported | Not reported | Not reported |
No
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Open-Label Period) - Eltrombopag | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- title
- Yes
- categories
- measurements
- group Id
- OG000
- value
- 2
- title
- No
- denoms
- counts
- group Id
- OG000
- value
- 2
- 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 worsening visual acuity due to cataracts at Follow-up Week 24 are presented. Change due to cataracts is categorized as "Yes" or "No."
- groups
- description
- Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: 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 and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
- id
- OG000
- title
- Part 2 (Open-Label Period) - Eltrombopag
- param Type
- NUMBER
- population Description
- Safety Population. Only those participants who had worsening visual acuity at Week 61 were analyzed.
- reporting Status
- POSTED
- time Frame
- Baseline and Follow-Up Week 24 (Week 61)
- title
- Number of Participants With Worsening Visual Acuity Due to Cataracts at Follow-Up Week 24
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice