TriangleNCT03525678 · OUTCOME
Number of Participants With Shift in Tear Break-up Time From >10 Seconds (Baseline) to <=5 Seconds (Worst Post-Baseline)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline and Up to 186 weeks
What was measured
Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with shift in tear break-up time from \>10 seconds (Baseline) to \<=5 seconds (worst post-Baseline) are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
Analysis population: Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
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) | 34 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 31 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 2 |
Reported measurements
Left eye,n=34,30,2
| Group | Source count |
|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 34 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 30 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 14 | Not reported | Not reported | Not reported | Not reported |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 12 | Not reported | Not reported | Not reported | Not reported |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 2 | Not reported | Not reported | Not reported | Not reported |
Right eye,n=30,31,2
| Group | Source count |
|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 30 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 31 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 11 | Not reported | Not reported | Not reported | Not reported |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 12 | Not reported | Not reported | Not reported | Not reported |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 30
- group Id
- OG002
- value
- 2
- units
- Participants
- title
- Left eye,n=34,30,2
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 31
- group Id
- OG002
- value
- 2
- units
- Participants
- title
- Right eye,n=30,31,2
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 31
- group Id
- OG002
- value
- 2
- units
- Participants
- description
- Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Number of participants with shift in tear break-up time from \>10 seconds (Baseline) to \<=5 seconds (worst post-Baseline) are presented. 3 participants out of 221 participants did not receive any study treatment and thus, were excluded from the Full Safety Population.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- Full Safety Population. All the participants in the study were included in the analysis (95, 99 and 24 Participants), but only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
- reporting Status
- POSTED
- time Frame
- Baseline and Up to 186 weeks
- title
- Number of Participants With Shift in Tear Break-up Time From >10 Seconds (Baseline) to <=5 Seconds (Worst Post-Baseline)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice