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NCT01018979 · BASELINE

Baseline characteristics

Safety and PK/PD of TG-0054 in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients · Source last updated 2021-05-11

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
      7
    2. group Id
      BG001
      value
      12
    3. group Id
      BG002
      value
      19
    units
    Participants
groups
  1. description
    TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
    id
    BG000
    title
    TG-0054 (2.24 mg/kg)
  2. description
    TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
    id
    BG001
    title
    TG-0054 (3.14 mg/kg)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          15.5
          value
          47.3
        2. group Id
          BG001
          spread
          9.3
          value
          52.4
        3. group Id
          BG002
          spread
          11.8
          value
          50.5
    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
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          11
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          8
        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
          spread
          10.1
          value
          162.7
        2. group Id
          BG001
          spread
          8.6
          value
          158.7
        3. group Id
          BG002
          spread
          9.1
          value
          160.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    centimeters
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          23.1
          value
          67.3
        2. group Id
          BG001
          spread
          10.2
          value
          60.6
        3. group Id
          BG002
          spread
          15.9
          value
          63.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kilogram
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.0
          value
          25.1
        2. group Id
          BG001
          spread
          3.0
          value
          24.0
        3. group Id
          BG002
          spread
          4.2
          value
          24.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Mass Index
    unit Of Measure
    kilogram/ meter^2
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
      title
      Multiple myeloma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          10
      title
      Non-Hodgkin lymphoma
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Hodgkin disease
    param Type
    NUMBER
    title
    Diagnosis
    unit Of Measure
    participants
population Description
19 subjects met all eligibility criteria and received at least one dose of TG-0054.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      7
    2. group Id
      BG001
      value
      12
    3. group Id
      BG002
      value
      19
    units
    Participants
groups
  1. description
    TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
    id
    BG000
    title
    TG-0054 (2.24 mg/kg)
  2. description
    TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
    id
    BG001
    title
    TG-0054 (3.14 mg/kg)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          15.5
          value
          47.3
        2. group Id
          BG001
          spread
          9.3
          value
          52.4
        3. group Id
          BG002
          spread
          11.8
          value
          50.5
    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
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          11
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          8
        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
          spread
          10.1
          value
          162.7
        2. group Id
          BG001
          spread
          8.6
          value
          158.7
        3. group Id
          BG002
          spread
          9.1
          value
          160.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    centimeters
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          23.1
          value
          67.3
        2. group Id
          BG001
          spread
          10.2
          value
          60.6
        3. group Id
          BG002
          spread
          15.9
          value
          63.1
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kilogram
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.0
          value
          25.1
        2. group Id
          BG001
          spread
          3.0
          value
          24.0
        3. group Id
          BG002
          spread
          4.2
          value
          24.4
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Mass Index
    unit Of Measure
    kilogram/ meter^2
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
      title
      Multiple myeloma
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          10
      title
      Non-Hodgkin lymphoma
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Hodgkin disease
    param Type
    NUMBER
    title
    Diagnosis
    unit Of Measure
    participants
population Description
19 subjects met all eligibility criteria and received at least one dose of TG-0054.

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Preserved source evidence · Not medical advice