NCT03477539 · 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
- 46
- units
- Participants
- groups
- description
- Patients receive daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, and on days 1 and 15 of cycles 3-4. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after completion of daratumumab cycle 2 or 4, patients undergo ASCT. Within 14 days after completion of day 100 visit post-SCT, patients receive daratumumab IV on day 1 and lenalidomide PO daily on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients who are still maintaining response continue to receive daratumumab IV every 3 months in the absence of disease progression or unacceptable toxicity.
- id
- BG000
- title
- Treatment (Daratumumab, ASCT, Lenalidomide)
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 8.17
- value
- 61.7
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 11
- title
- Female
- measurements
- group Id
- BG000
- value
- 35
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 4
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 42
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- 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
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- title
- Asian
- measurements
- group Id
- BG000
- value
- 1
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 3
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 42
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 0
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 46
- units
- Participants
- groups
- description
- Patients receive daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, and on days 1 and 15 of cycles 3-4. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 8 weeks after completion of daratumumab cycle 2 or 4, patients undergo ASCT. Within 14 days after completion of day 100 visit post-SCT, patients receive daratumumab IV on day 1 and lenalidomide PO daily on days 1-21. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients who are still maintaining response continue to receive daratumumab IV every 3 months in the absence of disease progression or unacceptable toxicity.
- id
- BG000
- title
- Treatment (Daratumumab, ASCT, Lenalidomide)
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 8.17
- value
- 61.7
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 11
- title
- Female
- measurements
- group Id
- BG000
- value
- 35
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 4
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 42
- title
- Not Hispanic or Latino
- measurements
- group Id
- BG000
- 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
- title
- American Indian or Alaska Native
- measurements
- group Id
- BG000
- value
- 0
- title
- Asian
- measurements
- group Id
- BG000
- value
- 1
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 3
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 42
- title
- White
- measurements
- group Id
- BG000
- value
- 0
- title
- More than one race
- measurements
- group Id
- BG000
- value
- 0
- title
- Unknown or Not Reported
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Race (NIH/OMB)
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice
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