Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01849848 · BASELINE

Baseline characteristics

Study of SyB L-0501 to Treat Relapsed/Refractory Multiple Myeloma · Source last updated 2015-02-06

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
      17
    units
    Participants
groups
  1. description
    SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
    id
    BG000
    title
    SyB L-0501
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.8
          value
          63.5
    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
          0
      title
      20-29 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      30-39 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      40-49 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      50-59 years
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      60-69 years
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      70-79 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          12
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      Immunoglobulin G
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Immunoglobulin A
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Immunoglobulin D
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Bence Jones type
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      κ
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      λ
    description
    One participant could carry multiple subtypes of myeloma.
    param Type
    NUMBER
    title
    Subtype of myeloma
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Absent
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      Present
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      Proteasome inhibitor
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      IMIDs
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      Alkylating agent
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      Other
    param Type
    NUMBER
    title
    Prior therapy
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      2
    description
    The criteria of Eastern Cooperative Oncology Group (ECOG) performance status are shown below. 0: Fully active, able to carry on all pre-disease performance without restriction , 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work , 2: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours
    param Type
    NUMBER
    title
    Performance status
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      III
    description
    The criteria of clinical disease stage (International Staging System) are shown below. stage I: Serum β2-microglobulin \< 3.5 mg/L plus serum albumin ≥ 3.5 g/dL, stage II: neither stage I nor III , stage III: Serum β2-microglobulin ≥ 5.5 mg/L
    param Type
    NUMBER
    title
    Clinical disease stage (International Staging System)
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      Absent
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Present
    param Type
    NUMBER
    title
    Medical history
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Absent
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      Present
    param Type
    NUMBER
    title
    Accompanying symptoms of the primary disease
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Absent
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      Present
    description
    A complication is a disease or condition that arises as a result of multiple myeloma.
    param Type
    NUMBER
    title
    Complication
    unit Of Measure
    participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.59
          value
          4.03
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Serum β2 microglobulin
    unit Of Measure
    mg/L
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.95
          value
          159.05
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    cm
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      17
    units
    Participants
groups
  1. description
    SyB L-0501: The administration of SyB L-0501 at 90 mg/m\^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
    id
    BG000
    title
    SyB L-0501
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.8
          value
          63.5
    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
          0
      title
      20-29 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      30-39 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      40-49 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      50-59 years
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      60-69 years
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      70-79 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          12
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      Immunoglobulin G
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      Immunoglobulin A
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Immunoglobulin D
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Bence Jones type
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      κ
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      λ
    description
    One participant could carry multiple subtypes of myeloma.
    param Type
    NUMBER
    title
    Subtype of myeloma
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Absent
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      Present
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      Proteasome inhibitor
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      IMIDs
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      Alkylating agent
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      Other
    param Type
    NUMBER
    title
    Prior therapy
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      2
    description
    The criteria of Eastern Cooperative Oncology Group (ECOG) performance status are shown below. 0: Fully active, able to carry on all pre-disease performance without restriction , 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work , 2: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours
    param Type
    NUMBER
    title
    Performance status
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          11
      title
      II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      III
    description
    The criteria of clinical disease stage (International Staging System) are shown below. stage I: Serum β2-microglobulin \< 3.5 mg/L plus serum albumin ≥ 3.5 g/dL, stage II: neither stage I nor III , stage III: Serum β2-microglobulin ≥ 5.5 mg/L
    param Type
    NUMBER
    title
    Clinical disease stage (International Staging System)
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
      title
      Absent
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Present
    param Type
    NUMBER
    title
    Medical history
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      title
      Absent
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
      title
      Present
    param Type
    NUMBER
    title
    Accompanying symptoms of the primary disease
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Absent
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      title
      Present
    description
    A complication is a disease or condition that arises as a result of multiple myeloma.
    param Type
    NUMBER
    title
    Complication
    unit Of Measure
    participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.59
          value
          4.03
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Serum β2 microglobulin
    unit Of Measure
    mg/L
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.95
          value
          159.05
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    cm

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice