TriangleNCT03525678 · OUTCOME
Number of Participants With Shift in Extraocular Muscle Movement From Yes (Baseline) to no (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. Extraocular muscle movement was assessed individually for each eye. Number of participants with shift in extraocular muscle movement from yes (Baseline) to no (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. 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) | 95 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 93 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 23 |
Reported measurements
Right eye,n=95,93,23
| Group | Source count |
|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 95 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 93 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 23 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 0 | Not reported | Not reported | Not reported | Not reported |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 4 | Not reported | Not reported | Not reported | Not reported |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 0 | Not reported | Not reported | Not reported | Not reported |
Left eye,n=93,92,22
| Group | Source count |
|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 93 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 92 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 22 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 0 | Not reported | Not reported | Not reported | Not reported |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 2 | Not reported | Not reported | Not reported | Not reported |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 95
- group Id
- OG001
- value
- 93
- group Id
- OG002
- value
- 23
- units
- Participants
- title
- Right eye,n=95,93,23
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 93
- group Id
- OG001
- value
- 92
- group Id
- OG002
- value
- 22
- units
- Participants
- title
- Left eye,n=93,92,22
- denoms
- counts
- group Id
- OG000
- value
- 95
- group Id
- OG001
- value
- 93
- group Id
- OG002
- value
- 23
- units
- Participants
- description
- Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Extraocular muscle movement was assessed individually for each eye. Number of participants with shift in extraocular muscle movement from yes (Baseline) to no (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. 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 Extraocular Muscle Movement From Yes (Baseline) to no (Worst Post-Baseline)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice