NCT03525678 · OUTCOME
Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores
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 (Day 1) 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. BCVA score was assessed individually for each eye. BCVA test scores were categorized as no change/improved vision, possible worsened vision and definite worsened vision. No change/improved vision was defined as a change from Baseline \<0.12 Logarithm of the Minimum Angle of Resolution (logMAR) score; a possible worsened vision was defined as a change from Baseline \>=0.12 to \<0.3 logMAR score; a definite worsened vision was defined as a change from Baseline \>=0.3 logMAR score. Data for worst-case change from Baseline is 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 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) | 88 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 94 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 24 |
|---|
Reported measurements
Left eye, no change/improved vision, n=88,94,24
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 88 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 94 |
|---|
| 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) | 35 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 45 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Left eye, possible worsened vision, n=88,94,24
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 88 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 94 |
|---|
| 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) | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
Left eye, definite worsened vision, n=88,94,24
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 88 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 94 |
|---|
| 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) | 42 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 34 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 16 | Not reported | Not reported | Not reported | Not reported |
|---|
Right eye, no change/improved vision, n=87,93,23
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 87 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 93 |
|---|
| 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) | 32 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 38 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Right eye, possible worsened vision, n=87,93,23
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 87 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 93 |
|---|
| 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) | 21 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 13 | 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 |
|---|
Right eye, definite worsened vision, n=87,93,23
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 87 |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 93 |
|---|
| 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) | 34 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 42 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 35
- group Id
- OG001
- value
- 45
- group Id
- OG002
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 88
- group Id
- OG001
- value
- 94
- group Id
- OG002
- value
- 24
- units
- Participants
- title
- Left eye, no change/improved vision, n=88,94,24
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 4
- denoms
- counts
- group Id
- OG000
- value
- 88
- group Id
- OG001
- value
- 94
- group Id
- OG002
- value
- 24
- units
- Participants
- title
- Left eye, possible worsened vision, n=88,94,24
- categories
- measurements
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 34
- group Id
- OG002
- value
- 16
- denoms
- counts
- group Id
- OG000
- value
- 88
- group Id
- OG001
- value
- 94
- group Id
- OG002
- value
- 24
- units
- Participants
- title
- Left eye, definite worsened vision, n=88,94,24
- categories
- measurements
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 38
- group Id
- OG002
- value
- 5
- denoms
- counts
- group Id
- OG000
- value
- 87
- group Id
- OG001
- value
- 93
- group Id
- OG002
- value
- 23
- units
- Participants
- title
- Right eye, no change/improved vision, n=87,93,23
- categories
- measurements
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 6
- denoms
- counts
- group Id
- OG000
- value
- 87
- group Id
- OG001
- value
- 93
- group Id
- OG002
- value
- 23
- units
- Participants
- title
- Right eye, possible worsened vision, n=87,93,23
- categories
- measurements
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 42
- group Id
- OG002
- value
- 12
- denoms
- counts
- group Id
- OG000
- value
- 87
- group Id
- OG001
- value
- 93
- group Id
- OG002
- value
- 23
- units
- Participants
- title
- Right eye, definite worsened vision, n=87,93,23
- denoms
- counts
- group Id
- OG000
- value
- 88
- group Id
- OG001
- value
- 94
- 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. BCVA score was assessed individually for each eye. BCVA test scores were categorized as no change/improved vision, possible worsened vision and definite worsened vision. No change/improved vision was defined as a change from Baseline \<0.12 Logarithm of the Minimum Angle of Resolution (logMAR) score; a possible worsened vision was defined as a change from Baseline \>=0.12 to \<0.3 logMAR score; a definite worsened vision was defined as a change from Baseline \>=0.3 logMAR score. Data for worst-case change from Baseline is 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 (Day 1) and Up to 186 weeks
- title
- Number of Participants With Change From Baseline in Best Corrected Visual Acuity (BCVA) Test Scores
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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