TriangleNCT03525678 · OUTCOME
Worst Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Score
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Scores on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline (Day 1) and up to Week 186
What was measured
The NEI-VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question to assess the impact of ocular toxicity on visual function. Items were coded to a 0 to 100 scale and averaged to calculate domains. Domain scores ranged from 0 to 100; higher scores are better. Therefore, increase in score means improvement. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for worst-case post Baseline is presented.
Analysis population: Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. Only those participants with data available at the specified data points were analyzed.
Groups in this outcome
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
| Group | Source count |
|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 83 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 92 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 22 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | -20.0 | 22.60 | Not reported | Not reported | Not reported |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | -19.6 | 21.66 | Not reported | Not reported | Not reported |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | -23.1 | 23.82 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 22.60
- value
- -20.0
- group Id
- OG001
- spread
- 21.66
- value
- -19.6
- group Id
- OG002
- spread
- 23.82
- value
- -23.1
- denoms
- counts
- group Id
- OG000
- value
- 83
- group Id
- OG001
- value
- 92
- group Id
- OG002
- value
- 22
- units
- Participants
- description
- The NEI-VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question to assess the impact of ocular toxicity on visual function. Items were coded to a 0 to 100 scale and averaged to calculate domains. Domain scores ranged from 0 to 100; higher scores are better. Therefore, increase in score means improvement. Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Data for worst-case post Baseline is presented.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
- id
- OG000
- title
- Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)
- description
- Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
- id
- OG001
- title
- Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)
- description
- Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
- id
- OG002
- title
- Main Study: GSK2857916 3.4 mg/kg (Lyophilized)
- param Type
- MEAN
- population Description
- Full Safety Population. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population. Only those participants with data available at the specified data points were analyzed.
- reporting Status
- POSTED
- time Frame
- Baseline (Day 1) and up to Week 186
- title
- Worst Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) Overall Composite Score
- type
- SECONDARY
- unit Of Measure
- Scores on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice