NCT00773838 · 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
- 143
- units
- Participants
- groups
- description
- Participants receive vorinostat 400 mg, orally, once daily (QD) on Days 1-14 of each 21-day treatment cycle and bortezomib 1.3mg/m\^2 intravenous (IV) injection QD on Days 1, 4, 8 and 11 of each 21-day treatment cycle for up to 26 cycles. Participants with progressive disease (PD) after 2 cycles of treatment or no change (NC) after 4 cycles of treatment receive additional treatment of Dexamethasone, 20 mg of total daily dose, orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle for up to 26 cycles. Eligible participants could receive additional treatment on an extension.
- id
- BG000
- title
- Vorinostat + Bortezomib
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 8.7
- value
- 62.1
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- Years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 56
- title
- Female
- measurements
- group Id
- BG000
- value
- 87
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 5
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 138
- 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
- 34
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 7
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 102
- 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
- population Description
- All allocated participants
Complete source fields
- denoms
- counts
- group Id
- BG000
- value
- 143
- units
- Participants
- groups
- description
- Participants receive vorinostat 400 mg, orally, once daily (QD) on Days 1-14 of each 21-day treatment cycle and bortezomib 1.3mg/m\^2 intravenous (IV) injection QD on Days 1, 4, 8 and 11 of each 21-day treatment cycle for up to 26 cycles. Participants with progressive disease (PD) after 2 cycles of treatment or no change (NC) after 4 cycles of treatment receive additional treatment of Dexamethasone, 20 mg of total daily dose, orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day treatment cycle for up to 26 cycles. Eligible participants could receive additional treatment on an extension.
- id
- BG000
- title
- Vorinostat + Bortezomib
- measures
- classes
- categories
- measurements
- group Id
- BG000
- spread
- 8.7
- value
- 62.1
- dispersion Type
- STANDARD_DEVIATION
- param Type
- MEAN
- title
- Age, Continuous
- unit Of Measure
- Years
- classes
- categories
- measurements
- group Id
- BG000
- value
- 56
- title
- Female
- measurements
- group Id
- BG000
- value
- 87
- title
- Male
- param Type
- COUNT_OF_PARTICIPANTS
- title
- Sex: Female, Male
- unit Of Measure
- Participants
- classes
- categories
- measurements
- group Id
- BG000
- value
- 5
- title
- Hispanic or Latino
- measurements
- group Id
- BG000
- value
- 138
- 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
- 34
- title
- Asian
- measurements
- group Id
- BG000
- value
- 0
- title
- Native Hawaiian or Other Pacific Islander
- measurements
- group Id
- BG000
- value
- 7
- title
- Black or African American
- measurements
- group Id
- BG000
- value
- 102
- 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
- population Description
- All allocated participants
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Preserved source evidence · Not medical advice
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