TriangleNCT05064358 · OUTCOME
Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of events
- Interval / dispersion
- Not reported
- Time frame
- At 3 months, 6 months, 9 months and 12 months
What was measured
Cumulative incidence of Grade 2 or above corneal events is defined as the percentage of corneal events of Grade 2 or above, as assessed using the KVA scale, within a specific time interval. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.
Analysis population: Safety Population. Only those participants who experienced corneal events (KVA scale) of Grade 2 or above 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) | 25 |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | 16 |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | 17 |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | 15 |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | 11 |
Reported measurements
At 3 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | 59 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | 32 | Not reported | Not reported | Not reported | Not reported |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | 36 | Not reported | Not reported | Not reported | Not reported |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | 33 | Not reported | Not reported | Not reported | Not reported |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | 53 | Not reported | Not reported | Not reported | Not reported |
At 6 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | 64 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | 37 | Not reported | Not reported | Not reported | Not reported |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | 41 | Not reported | Not reported | Not reported | Not reported |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | 38 | Not reported | Not reported | Not reported | Not reported |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | 59 | Not reported | Not reported | Not reported | Not reported |
At 9 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | 64 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | 40 | Not reported | Not reported | Not reported | Not reported |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | 41 | Not reported | Not reported | Not reported | Not reported |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | 38 | Not reported | Not reported | Not reported | Not reported |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | 59 | Not reported | Not reported | Not reported | Not reported |
At 12 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | 64 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | 40 | Not reported | Not reported | Not reported | Not reported |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | 44 | Not reported | Not reported | Not reported | Not reported |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | 38 | Not reported | Not reported | Not reported | Not reported |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | 59 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 59
- group Id
- OG001
- value
- 32
- group Id
- OG002
- value
- 36
- group Id
- OG003
- value
- 33
- group Id
- OG004
- value
- 53
- title
- At 3 months
- categories
- measurements
- group Id
- OG000
- value
- 64
- group Id
- OG001
- value
- 37
- group Id
- OG002
- value
- 41
- group Id
- OG003
- value
- 38
- group Id
- OG004
- value
- 59
- title
- At 6 months
- categories
- measurements
- group Id
- OG000
- value
- 64
- group Id
- OG001
- value
- 40
- group Id
- OG002
- value
- 41
- group Id
- OG003
- value
- 38
- group Id
- OG004
- value
- 59
- title
- At 9 months
- categories
- measurements
- group Id
- OG000
- value
- 64
- group Id
- OG001
- value
- 40
- group Id
- OG002
- value
- 44
- group Id
- OG003
- value
- 38
- group Id
- OG004
- value
- 59
- title
- At 12 months
- denoms
- counts
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 17
- group Id
- OG003
- value
- 15
- group Id
- OG004
- value
- 11
- units
- Participants
- description
- Cumulative incidence of Grade 2 or above corneal events is defined as the percentage of corneal events of Grade 2 or above, as assessed using the KVA scale, within a specific time interval. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.
- 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
- NUMBER
- population Description
- Safety Population. Only those participants who experienced corneal events (KVA scale) of Grade 2 or above have been analyzed.
- reporting Status
- POSTED
- time Frame
- At 3 months, 6 months, 9 months and 12 months
- title
- Cumulative Incidence of Grade 2 or Above Corneal Events (KVA Scale)
- type
- SECONDARY
- unit Of Measure
- Percentage of events
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Preserved source evidence · Not medical advice