NCT05064358 · BASELINE
Baseline characteristics
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- denoms
- counts
- group Id
- BG000
- value
- 40
- group Id
- BG001
- value
- 40
- group Id
- BG002
- value
- 40
- group Id
- BG003
- value
- 40
- group Id
- BG004
- value
- 17
- group Id
- BG005
- value
- 177
- units
- Participants
- 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
- BG000
- 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
- BG001
- 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
- BG002
- 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
- BG003
- 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
- BG004
- title
- Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
- description
- Total of all reporting groups
- id
- BG005
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 10.36
- value
- 66.6
- group Id
- BG001
- spread
- 9.02
- value
- 63.0
- group Id
- BG002
- spread
- 9.92
- value
- 63.7
- group Id
- BG003
- spread
- 8.87
- value
- 65.4
- group Id
- BG004
- spread
- 10.42
- value
- 67.1
- group Id
- BG005
- spread
- 9.66
- value
- 64.9
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- YEARS
- classes
- categories
- measurements
- group Id
- BG000
- value
- 19
- group Id
- BG001
- value
- 21
- group Id
- BG002
- value
- 19
- group Id
- BG003
- value
- 16
- group Id
- BG004
- value
- 8
- group Id
- BG005
- value
- 83
- title
- Female
- measurements
- group Id
- BG000
- value
- 21
- group Id
- BG001
- value
- 19
- group Id
- BG002
- value
- 21
- group Id
- BG003
- value
- 24
- group Id
- BG004
- value
- 9
- group Id
- BG005
- value
- 94
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 13
- group Id
- BG001
- value
- 9
- group Id
- BG002
- value
- 12
- group Id
- BG003
- value
- 6
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 46
- title
- Hispanic or Latino
- categories
- measurements
- group Id
- BG000
- value
- 27
- group Id
- BG001
- value
- 31
- group Id
- BG002
- value
- 28
- group Id
- BG003
- value
- 34
- group Id
- BG004
- value
- 11
- group Id
- BG005
- value
- 131
- title
- Not Hispanic or Latino
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race/Ethnicity, Customized
- unit Of Measure
- Participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 40
- group Id
- BG001
- value
- 40
- group Id
- BG002
- value
- 40
- group Id
- BG003
- value
- 40
- group Id
- BG004
- value
- 17
- group Id
- BG005
- value
- 177
- units
- Participants
- 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
- BG000
- 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
- BG001
- 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
- BG002
- 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
- BG003
- 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
- BG004
- title
- Arm E: Belantamab Mafodotin 1.9 mg/kg Q6W (Based on OSDI + Visual Acuity [VA] Assessment)
- description
- Total of all reporting groups
- id
- BG005
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 10.36
- value
- 66.6
- group Id
- BG001
- spread
- 9.02
- value
- 63.0
- group Id
- BG002
- spread
- 9.92
- value
- 63.7
- group Id
- BG003
- spread
- 8.87
- value
- 65.4
- group Id
- BG004
- spread
- 10.42
- value
- 67.1
- group Id
- BG005
- spread
- 9.66
- value
- 64.9
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- YEARS
- classes
- categories
- measurements
- group Id
- BG000
- value
- 19
- group Id
- BG001
- value
- 21
- group Id
- BG002
- value
- 19
- group Id
- BG003
- value
- 16
- group Id
- BG004
- value
- 8
- group Id
- BG005
- value
- 83
- title
- Female
- measurements
- group Id
- BG000
- value
- 21
- group Id
- BG001
- value
- 19
- group Id
- BG002
- value
- 21
- group Id
- BG003
- value
- 24
- group Id
- BG004
- value
- 9
- group Id
- BG005
- value
- 94
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 13
- group Id
- BG001
- value
- 9
- group Id
- BG002
- value
- 12
- group Id
- BG003
- value
- 6
- group Id
- BG004
- value
- 6
- group Id
- BG005
- value
- 46
- title
- Hispanic or Latino
- categories
- measurements
- group Id
- BG000
- value
- 27
- group Id
- BG001
- value
- 31
- group Id
- BG002
- value
- 28
- group Id
- BG003
- value
- 34
- group Id
- BG004
- value
- 11
- group Id
- BG005
- value
- 131
- title
- Not Hispanic or Latino
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race/Ethnicity, Customized
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice
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