TriangleNCT05064358 · OUTCOME
Duration of Corneal Events of Grade 2 or Above
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Days
- Interval / dispersion
- Full Range
- Time frame
- Up to 152 weeks
What was measured
Duration of corneal events is defined for each participant as the sum of duration of all the corneal AEs. The duration is defined as time from onset of any corneal events (KVA scale) of Grade 2 or above to the first time resolution to baseline, Grade 1 or below. It required at least one day gap between the resolution of all events from first occurrence to the onset of next occurrence.
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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | 63.0 | Not reported | 22 | 296 | Not reported |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | 67.5 | Not reported | 13 | 233 | Not reported |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | 46.5 | Not reported | 20 | 162 | Not reported |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | 53.5 | Not reported | 20 | 148 | Not reported |
| Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment) | 44.0 | Not reported | 21 | 274 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 22
- upper Limit
- 296
- value
- 63.0
- group Id
- OG001
- lower Limit
- 13
- upper Limit
- 233
- value
- 67.5
- group Id
- OG002
- lower Limit
- 20
- upper Limit
- 162
- value
- 46.5
- group Id
- OG003
- lower Limit
- 20
- upper Limit
- 148
- value
- 53.5
- group Id
- OG004
- lower Limit
- 21
- upper Limit
- 274
- value
- 44.0
- 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
- Duration of corneal events is defined for each participant as the sum of duration of all the corneal AEs. The duration is defined as time from onset of any corneal events (KVA scale) of Grade 2 or above to the first time resolution to baseline, Grade 1 or below. It required at least one day gap between the resolution of all events from first occurrence to the onset of next occurrence.
- dispersion Type
- Full Range
- 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
- MEDIAN
- 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
- Up to 152 weeks
- title
- Duration of Corneal Events of Grade 2 or Above
- type
- SECONDARY
- unit Of Measure
- Days
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Preserved source evidence · Not medical advice