TriangleNCT05064358 · OUTCOME
Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores
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 152 weeks
What was measured
Change in BCVA is defined as change in logarithm of the minimum angle of resolution (logMAR) units compared with baseline or the first visit after the cataract surgery. BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any change from baseline categories is presented for right and left eyes. No change/improved vision is defined as a change from baseline \<0.1; a possible worsened vision is defined as a change from baseline \>=0.1 to \<=0.3; a definite worsened vision is defined as a change from baseline \>0.3 logMAR score. Improvement in BCVA is represented by a reduction in logMAR score from baseline, while worsening in BCVA is represented by an increase in logMAR score from baseline.
Analysis population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Groups in this outcome
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
| Group | Source count |
|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | 22 |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | 24 |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | 23 |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | 29 |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | 11 |
Reported measurements
Left Eye
| Group | Source count |
|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | 22 |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | 24 |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | 23 |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | 29 |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | 11 |
No change
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | 16 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | 20 | Not reported | Not reported | Not reported | Not reported |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | 19 | Not reported | Not reported | Not reported | Not reported |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | 27 | Not reported | Not reported | Not reported | Not reported |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | 8 | Not reported | Not reported | Not reported | Not reported |
Possible worsened vision
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | 2 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | 3 | Not reported | Not reported | Not reported | Not reported |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | 3 | Not reported | Not reported | Not reported | Not reported |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | 1 | Not reported | Not reported | Not reported | Not reported |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | 1 | Not reported | Not reported | Not reported | Not reported |
Definite worsened vision
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | 4 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | 1 | Not reported | Not reported | Not reported | Not reported |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | 1 | Not reported | Not reported | Not reported | Not reported |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | 1 | Not reported | Not reported | Not reported | Not reported |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | 2 | Not reported | Not reported | Not reported | Not reported |
Right Eye
| Group | Source count |
|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | 21 |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | 24 |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | 23 |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | 29 |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | 11 |
No change
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | 16 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | 18 | Not reported | Not reported | Not reported | Not reported |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | 21 | Not reported | Not reported | Not reported | Not reported |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | 27 | Not reported | Not reported | Not reported | Not reported |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | 10 | Not reported | Not reported | Not reported | Not reported |
Possible worsened vision
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | 4 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | 5 | Not reported | Not reported | Not reported | Not reported |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | 2 | Not reported | Not reported | Not reported | Not reported |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | 2 | Not reported | Not reported | Not reported | Not reported |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | 1 | Not reported | Not reported | Not reported | Not reported |
Definite worsened vision
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | 1 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | 1 | Not reported | Not reported | Not reported | Not reported |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 19
- group Id
- OG003
- value
- 27
- group Id
- OG004
- value
- 8
- title
- No change
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- title
- Possible worsened vision
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- title
- Definite worsened vision
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 23
- group Id
- OG003
- value
- 29
- group Id
- OG004
- value
- 11
- units
- Participants
- title
- Left Eye
- categories
- measurements
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 18
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 27
- group Id
- OG004
- value
- 10
- title
- No change
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- title
- Possible worsened vision
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Definite worsened vision
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 23
- group Id
- OG003
- value
- 29
- group Id
- OG004
- value
- 11
- units
- Participants
- title
- Right Eye
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 23
- group Id
- OG003
- value
- 29
- group Id
- OG004
- value
- 11
- units
- Participants
- description
- Change in BCVA is defined as change in logarithm of the minimum angle of resolution (logMAR) units compared with baseline or the first visit after the cataract surgery. BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any change from baseline categories is presented for right and left eyes. No change/improved vision is defined as a change from baseline \<0.1; a possible worsened vision is defined as a change from baseline \>=0.1 to \<=0.3; a definite worsened vision is defined as a change from baseline \>0.3 logMAR score. Improvement in BCVA is represented by a reduction in logMAR score from baseline, while worsening in BCVA is represented by an increase in logMAR score from baseline.
- groups
- description
- Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
- id
- OG000
- title
- Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
- description
- Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
- id
- OG001
- title
- Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
- description
- Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
- id
- OG002
- title
- Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
- description
- Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
- id
- OG003
- title
- Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
- description
- Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death. For this arm, dose modification decisions were determined by the results of the Ocular Surface Disease Index (OSDI) questionnaire or VA assessments using Snellen chart. The OSDI scale assesses the severity of eye symptoms and their impact and Snellen chart is for the assessment of visual acuity.
- id
- OG004
- title
- Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Population. Only those participants with data available at specified time points have been analyzed.
- reporting Status
- POSTED
- time Frame
- Baseline (Day 1) and up to 152 weeks
- title
- Number of Participants With Change in Best Corrected Visual Acuity Test (BCVA) Scores
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice