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NCT01556438 · BASELINE

Baseline characteristics

Study of Tabalumab (LY2127399) in Japanese Participants With Relapsed or Refactory Multiple Myeloma · Source last updated 2019-03-20

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
      4
    2. group Id
      BG001
      value
      12
    3. group Id
      BG002
      value
      16
    units
    Participants
groups
  1. description
    Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m\^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.
    id
    BG000
    title
    100 mg Tabalumab+BTZ IV+Dex
  2. description
    Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively).
    id
    BG001
    title
    300 mg Tabalumab+BTZ +Dex
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          66.4
          upper Limit
          80.2
          value
          70.7
        2. group Id
          BG001
          lower Limit
          52.0
          upper Limit
          82.1
          value
          71.3
        3. group Id
          BG002
          lower Limit
          52.0
          upper Limit
          82.1
          value
          71.1
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          10
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          16
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          16
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          16
      title
      Japan
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
All participants who received at least 1 dose of study drug. 300 mg LY2127399 group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      4
    2. group Id
      BG001
      value
      12
    3. group Id
      BG002
      value
      16
    units
    Participants
groups
  1. description
    Cohort 1. 100 mg tabalumab (LY2127399) intravenously (IV) on day 1 of each cycle. Bortezomib (BTZ), 1.3 milligram per square meter (mg/m\^2), IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dexamethasone (Dex), 20 mg/day, on day of and day after BTZ.
    id
    BG000
    title
    100 mg Tabalumab+BTZ IV+Dex
  2. description
    Cohort 2. 300 mg tabalumab (LY2127399) IV on day 1 of each cycle. BTZ, 1.3 mg/m\^2, IV on days 1, 4, 8, 11 of Cycle 1-8, then on days 1, 8, 15, 22 from Cycle 9 onward. Oral dex, 20 mg/day, on day of and day after BTZ subcutaneously or intravenously (SC, IV respectively).
    id
    BG001
    title
    300 mg Tabalumab+BTZ +Dex
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          66.4
          upper Limit
          80.2
          value
          70.7
        2. group Id
          BG001
          lower Limit
          52.0
          upper Limit
          82.1
          value
          71.3
        3. group Id
          BG002
          lower Limit
          52.0
          upper Limit
          82.1
          value
          71.1
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          10
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          6
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          16
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          16
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          16
      title
      Japan
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
All participants who received at least 1 dose of study drug. 300 mg LY2127399 group administered BTZ IV or SC data were combined per protocol, BTZ was a supplemental therapy for participants.

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Preserved source evidence · Not medical advice