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NCT00765102 · BASELINE

Baseline characteristics

Trial of Romidepsin and Bortezomib for Multiple Myeloma · Source last updated 2019-11-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      32
    units
    Participants
groups
  1. description
    Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period. Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.
    id
    BG000
    title
    Romidepsin + Bortezomib
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.11
          value
          63.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Native Hawaiian or Other Pacific Islander
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Black or African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          24
      title
      White
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      Status 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      Status 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Status 2
    description
    Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects a patient. The scale ranges from 0 (fully active) to 5 (dead). 0=Fully active without restriction; 1= Restricted in physically strenuous activity; 2= Ambulatory, capable of all selfcare.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      32
    units
    Participants
groups
  1. description
    Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period. Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.
    id
    BG000
    title
    Romidepsin + Bortezomib
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.11
          value
          63.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          14
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Native Hawaiian or Other Pacific Islander
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Black or African American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          24
      title
      White
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Other
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      Status 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      Status 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Status 2
    description
    Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects a patient. The scale ranges from 0 (fully active) to 5 (dead). 0=Fully active without restriction; 1= Restricted in physically strenuous activity; 2= Ambulatory, capable of all selfcare.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice