NCT05787496 · 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
- 3
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 11
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 3
- group Id
- BG006
- value
- 28
- units
- Participants
- groups
- description
- Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter. NC525: Monoclonal antibody specific for LAIR-1
- id
- BG000
- title
- 2mg/kg NC525
- description
- Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW. NC525: Monoclonal antibody specific for LAIR-1
- id
- BG001
- title
- 2.5mg/kg NC525
- description
- Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
- id
- BG002
- title
- 4.5mg/kg NC525
- description
- Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
- id
- BG003
- title
- 9mg/kg NC525
- description
- Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
- id
- BG004
- title
- 13.5mg/kg NC525
- description
- Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
- id
- BG005
- title
- 18mg/kg NC525
- description
- Total of all reporting groups
- id
- BG006
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 8.96
- value
- 61.7
- group Id
- BG001
- spread
- 19.87
- value
- 65.8
- group Id
- BG002
- spread
- 10.54
- value
- 66.0
- group Id
- BG003
- spread
- 12.86
- value
- 69.6
- group Id
- BG004
- spread
- 17.97
- value
- 52.8
- group Id
- BG005
- spread
- 24.01
- value
- 56.7
- group Id
- BG006
- spread
- 15.40
- value
- 64.0
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 13
- title
- Female
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 15
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 6
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 9
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 22
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 2
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 2
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 9
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 21
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 1
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 2
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 11
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 3
- group Id
- BG006
- value
- 28
- title
- United States
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 11
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 3
- group Id
- BG006
- value
- 28
- units
- Participants
- groups
- description
- Subjects received NC525 IV at 2mg/kg bi-weekly (Q2W) for Cycles 1-6, followed by every 4 weeks (Q4W) thereafter. NC525: Monoclonal antibody specific for LAIR-1
- id
- BG000
- title
- 2mg/kg NC525
- description
- Subjects received NC525 IV at 2.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. Subjects in Cohort 2 initially received 3mg/kg weekly but dose was reduced to 2.5mg/kg weekly at FDA request due to change in dosing frequency from Q2W to QW. NC525: Monoclonal antibody specific for LAIR-1
- id
- BG001
- title
- 2.5mg/kg NC525
- description
- Subjects received NC525 IV at 4.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
- id
- BG002
- title
- 4.5mg/kg NC525
- description
- Subjects received NC525 IV at 9mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
- id
- BG003
- title
- 9mg/kg NC525
- description
- Subjects received NC525 IV at 13.5mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
- id
- BG004
- title
- 13.5mg/kg NC525
- description
- Subjects received NC525 IV at 18mg/kg weekly (QW) until overall response (e.g., CR, CRh, or CRi) is achieved, at which time they may switch to Q2W dosing. NC525: Monoclonal antibody specific for LAIR-1
- id
- BG005
- title
- 18mg/kg NC525
- description
- Total of all reporting groups
- id
- BG006
- title
- Total
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 8.96
- value
- 61.7
- group Id
- BG001
- spread
- 19.87
- value
- 65.8
- group Id
- BG002
- spread
- 10.54
- value
- 66.0
- group Id
- BG003
- spread
- 12.86
- value
- 69.6
- group Id
- BG004
- spread
- 17.97
- value
- 52.8
- group Id
- BG005
- spread
- 24.01
- value
- 56.7
- group Id
- BG006
- spread
- 15.40
- value
- 64.0
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 2
- group Id
- BG003
- value
- 4
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 13
- title
- Female
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 1
- group Id
- BG003
- value
- 7
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 15
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 2
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 6
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 2
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 9
- group Id
- BG004
- value
- 3
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 22
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Ethnicity (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 1
- group Id
- BG006
- value
- 2
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 1
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 2
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 2
- group Id
- BG001
- value
- 3
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 9
- group Id
- BG004
- value
- 2
- group Id
- BG005
- value
- 2
- group Id
- BG006
- value
- 21
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 0
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 0
- group Id
- BG004
- value
- 1
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 1
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 0
- group Id
- BG001
- value
- 1
- group Id
- BG002
- value
- 0
- group Id
- BG003
- value
- 1
- group Id
- BG004
- value
- 0
- group Id
- BG005
- value
- 0
- group Id
- BG006
- value
- 2
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 3
- group Id
- BG001
- value
- 4
- group Id
- BG002
- value
- 3
- group Id
- BG003
- value
- 11
- group Id
- BG004
- value
- 4
- group Id
- BG005
- value
- 3
- group Id
- BG006
- value
- 28
- title
- United States
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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