NCT03525678 · OUTCOME
Number of Participants With Shift in Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline)
A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody · Source last updated 2025-09-03
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. Corneal epithelium findings like active edema, active opacity, corneal neovascularization (CN), corneal ulcer, epithelial microcystic edema (EME) and subepithelial were performed using a slit lamp. Number of participants with shift in corneal epithelium findings from no (Baseline) to yes (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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 95 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 99 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 24 |
|---|
Reported measurements
Active edema, Right eye, n=94,99,24
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 94 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 99 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 24 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 5 | 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 |
|---|
Active edema, Left eye,n=95,99,24
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 95 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 99 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 24 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 4 | 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) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Active opacity, Right eye,n=93,97,24
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 93 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 97 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 24 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Active opacity, Left eye,n=94,95,24
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 94 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 95 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 24 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 4 | 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) | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Corneal Neovascularization, Right eye,n=93,99,24
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 93 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 99 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 24 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 1 | 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 |
|---|
Corneal Neovascularization, Left eye,n=93,99,23
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 93 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 99 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 23 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 0 | 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 |
|---|
Corneal ulcer, Right eye,n=61,60,22
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 61 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 60 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 22 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 1 | 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 |
|---|
Corneal ulcer, Left eye,n=63,61,20
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 63 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 61 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 20 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 1 | 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 |
|---|
Epithelial Microcystic Edema, Right eye,n=95,99,24
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 95 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 99 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 24 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 24 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
Epithelial Microcystic Edema, Left eye,n=95,99,23
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 95 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 99 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 23 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 16 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 25 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
Subepithelial haze, Right eye,n=95,98,24
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 95 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 98 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 24 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 18 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
Subepithelial haze, Left eye,n=95,97,23
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 95 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 97 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 23 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 18 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 29 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 94
- group Id
- OG001
- value
- 99
- group Id
- OG002
- value
- 24
- units
- Participants
- title
- Active edema, Right eye, n=94,99,24
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 95
- group Id
- OG001
- value
- 99
- group Id
- OG002
- value
- 24
- units
- Participants
- title
- Active edema, Left eye,n=95,99,24
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 93
- group Id
- OG001
- value
- 97
- group Id
- OG002
- value
- 24
- units
- Participants
- title
- Active opacity, Right eye,n=93,97,24
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 94
- group Id
- OG001
- value
- 95
- group Id
- OG002
- value
- 24
- units
- Participants
- title
- Active opacity, Left eye,n=94,95,24
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 93
- group Id
- OG001
- value
- 99
- group Id
- OG002
- value
- 24
- units
- Participants
- title
- Corneal Neovascularization, Right eye,n=93,99,24
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 93
- group Id
- OG001
- value
- 99
- group Id
- OG002
- value
- 23
- units
- Participants
- title
- Corneal Neovascularization, Left eye,n=93,99,23
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 60
- group Id
- OG002
- value
- 22
- units
- Participants
- title
- Corneal ulcer, Right eye,n=61,60,22
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 63
- group Id
- OG001
- value
- 61
- group Id
- OG002
- value
- 20
- units
- Participants
- title
- Corneal ulcer, Left eye,n=63,61,20
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 9
- denoms
- counts
- group Id
- OG000
- value
- 95
- group Id
- OG001
- value
- 99
- group Id
- OG002
- value
- 24
- units
- Participants
- title
- Epithelial Microcystic Edema, Right eye,n=95,99,24
- categories
- measurements
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 25
- group Id
- OG002
- value
- 8
- denoms
- counts
- group Id
- OG000
- value
- 95
- group Id
- OG001
- value
- 99
- group Id
- OG002
- value
- 23
- units
- Participants
- title
- Epithelial Microcystic Edema, Left eye,n=95,99,23
- categories
- measurements
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 28
- group Id
- OG002
- value
- 8
- denoms
- counts
- group Id
- OG000
- value
- 95
- group Id
- OG001
- value
- 98
- group Id
- OG002
- value
- 24
- units
- Participants
- title
- Subepithelial haze, Right eye,n=95,98,24
- categories
- measurements
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 29
- group Id
- OG002
- value
- 6
- denoms
- counts
- group Id
- OG000
- value
- 95
- group Id
- OG001
- value
- 97
- group Id
- OG002
- value
- 23
- units
- Participants
- title
- Subepithelial haze, Left eye,n=95,97,23
- denoms
- counts
- group Id
- OG000
- value
- 95
- group Id
- OG001
- value
- 99
- group Id
- OG002
- value
- 24
- units
- Participants
- description
- Baseline was defined as latest pre-dose assessment (Day 1) with a non-missing value, including unscheduled visits. Corneal epithelium findings like active edema, active opacity, corneal neovascularization (CN), corneal ulcer, epithelial microcystic edema (EME) and subepithelial were performed using a slit lamp. Number of participants with shift in corneal epithelium findings from no (Baseline) to yes (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 Corneal Epithelium Findings From no (Baseline) to Yes (Worst Post-Baseline)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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