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NCT01179490 · BASELINE

Baseline characteristics

Efficacy and Safety Study of SyB L-0501 for Patients With Multiple Myeloma · Source last updated 2013-03-18

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
      5
    units
    Participants
groups
  1. description
    SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
    id
    BG000
    title
    SyB L-0501 + Prednisolone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          2.3
          value
          69.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEDIAN
    title
    Age Continuous
    unit Of Measure
    Year
  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
          0
      title
      40-49 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      50-59 years
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      60-69 years
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      70-84 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        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
          5
      title
      No
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Yes
    description
    Condition with symptoms of Multiple Myeloma (Development of hyperviscosity syndrome, amyloidosis, Bacterial infection twice or more in a year)
    param Type
    NUMBER
    title
    Condition with symptoms of Multiple Myeloma
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      No
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Yes
    param Type
    NUMBER
    title
    Previous treatment of multiple myeloma
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Age 66 years or older
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Presence of cardiopulmonary dysfunction
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Renal dysfunction
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Other
    param Type
    NUMBER
    title
    Reason for not eligible for hematopoietic stem cell transplantation
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      3
    description
    0: Asymptomatic 1: Symptomatic but completely ambulatory 2: Symptomatic, \<50% in bed during the day 3: Symptomatic, \>50% in bed, but not bedbound
    param Type
    NUMBER
    title
    Performance status (P.S.)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Stage III
    description
    Stage I: Serum β2-microglobulin (β2M) \< 3.5 mg/L and serum albumin ≥ 3.5 g/dL) Stage II: Serum β2M ≥3.5 - \< 5.5 mg/L; or serum β2M \< 3.5 mg/L and serum albumin \< 3.5 g/dL) Stage III: (Serum β2M ≥ 5.5 mg/L)
    param Type
    NUMBER
    title
    Clinical stage [International staging system (ISS) category]
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      No
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Yes
    param Type
    NUMBER
    title
    Previous history of multiple myeloma
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      No
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Yes
    param Type
    NUMBER
    title
    Associated symptom of the primary disease
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      No
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Yes
    param Type
    NUMBER
    title
    Complications of multiple myeloma
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.48
          value
          5.00
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEDIAN
    title
    Serum β2M in clinical stage
    unit Of Measure
    mg/L
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      5
    units
    Participants
groups
  1. description
    SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
    id
    BG000
    title
    SyB L-0501 + Prednisolone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          2.3
          value
          69.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEDIAN
    title
    Age Continuous
    unit Of Measure
    Year
  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
          0
      title
      40-49 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      50-59 years
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      60-69 years
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      70-84 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        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
          5
      title
      No
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Yes
    description
    Condition with symptoms of Multiple Myeloma (Development of hyperviscosity syndrome, amyloidosis, Bacterial infection twice or more in a year)
    param Type
    NUMBER
    title
    Condition with symptoms of Multiple Myeloma
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      No
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Yes
    param Type
    NUMBER
    title
    Previous treatment of multiple myeloma
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Age 66 years or older
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Presence of cardiopulmonary dysfunction
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Renal dysfunction
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Other
    param Type
    NUMBER
    title
    Reason for not eligible for hematopoietic stem cell transplantation
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      3
    description
    0: Asymptomatic 1: Symptomatic but completely ambulatory 2: Symptomatic, \<50% in bed during the day 3: Symptomatic, \>50% in bed, but not bedbound
    param Type
    NUMBER
    title
    Performance status (P.S.)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Stage III
    description
    Stage I: Serum β2-microglobulin (β2M) \< 3.5 mg/L and serum albumin ≥ 3.5 g/dL) Stage II: Serum β2M ≥3.5 - \< 5.5 mg/L; or serum β2M \< 3.5 mg/L and serum albumin \< 3.5 g/dL) Stage III: (Serum β2M ≥ 5.5 mg/L)
    param Type
    NUMBER
    title
    Clinical stage [International staging system (ISS) category]
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      No
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      Yes
    param Type
    NUMBER
    title
    Previous history of multiple myeloma
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      No
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Yes
    param Type
    NUMBER
    title
    Associated symptom of the primary disease
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      No
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Yes
    param Type
    NUMBER
    title
    Complications of multiple myeloma
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.48
          value
          5.00
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEDIAN
    title
    Serum β2M in clinical stage
    unit Of Measure
    mg/L

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Preserved source evidence · Not medical advice