NCT01380145 · 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
- 13
- units
- Participants
- groups
- description
- Includes all subjects enrolled in the study.
- id
- BG000
- title
- All Enrolled Subjects
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 10.33
- value
- 54.3
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 4
- title
- Female
- measurements
- group Id
- BG000
- value
- 9
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 12
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 1
- 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
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 2
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 10
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 1
- 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
- 13
- title
- United States
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 4.74
- value
- 30.2
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Body Mass Index
- unit Of Measure
- kg/m^2
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- title
- Complete Response
- categories
- measurements
- group Id
- BG000
- value
- 12
- title
- Very Good Partial Response
- description
- Complete Response (CR): negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, \<5% plasma cells in bone marrow Stringent CR (sCR): CR + normal free light chain (FLC) ratio and absence of clonal cells in bone marrow Very Good Partial Response (VGPR): Serum/urine M-component detectable by immunofixation but not electropheresis OR ≥90% reduction in serum M-component + urine M-component \<100 mg/24 hrs PR: ≥50% reduction of serum M-protein and reduction in 24-hr urinary M-protein by ≥90% or to \<200 mg/24 hrs Stable disease: not response or progression
- param Type
- NUMBER
- title
- Response to Prior Induction Therapy
- unit Of Measure
- participants
- population Description
- Includes all subjects enrolled in the study.
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 13
- units
- Participants
- groups
- description
- Includes all subjects enrolled in the study.
- id
- BG000
- title
- All Enrolled Subjects
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 10.33
- value
- 54.3
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 4
- title
- Female
- measurements
- group Id
- BG000
- value
- 9
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 0
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 12
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 1
- 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
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 2
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 10
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 1
- 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
- 13
- title
- United States
- param Type
- NUMBER
- title
- Region of Enrollment
- unit Of Measure
- participants
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 4.74
- value
- 30.2
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Body Mass Index
- unit Of Measure
- kg/m^2
- classes
- categories
- measurements
- group Id
- BG000
- value
- 1
- title
- Complete Response
- categories
- measurements
- group Id
- BG000
- value
- 12
- title
- Very Good Partial Response
- description
- Complete Response (CR): negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, \<5% plasma cells in bone marrow Stringent CR (sCR): CR + normal free light chain (FLC) ratio and absence of clonal cells in bone marrow Very Good Partial Response (VGPR): Serum/urine M-component detectable by immunofixation but not electropheresis OR ≥90% reduction in serum M-component + urine M-component \<100 mg/24 hrs PR: ≥50% reduction of serum M-protein and reduction in 24-hr urinary M-protein by ≥90% or to \<200 mg/24 hrs Stable disease: not response or progression
- param Type
- NUMBER
- title
- Response to Prior Induction Therapy
- unit Of Measure
- participants
- population Description
- Includes all subjects enrolled in the study.
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Preserved source evidence · Not medical advice
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