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NCT02268253 · BASELINE

Baseline characteristics

Tagraxofusp (SL-401) in Participants With Chronic Myelomonocytic Leukemia (CMML) and Myelofibrosis (MF) · Source last updated 2025-01-06

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
      1
    2. group Id
      BG001
      value
      2
    3. group Id
      BG002
      value
      39
    4. group Id
      BG003
      value
      2
    5. group Id
      BG004
      value
      1
    6. group Id
      BG005
      value
      36
    7. group Id
      BG006
      value
      1
    8. group Id
      BG007
      value
      82
    units
    Participants
groups
  1. description
    Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
    id
    BG000
    title
    Dose Level 1 -Tagraxofusp - 7 µg/kg/Day - Chronic Myelomonocytic Leukemia
  2. description
    Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
    id
    BG001
    title
    Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Chronic Myelomonocytic Leukemia
  3. description
    Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
    id
    BG002
    title
    Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Chronic Myelomonocytic Leukemia
  4. description
    Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
    id
    BG003
    title
    Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Myelofibrosis
  5. description
    Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
    id
    BG004
    title
    Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Myelofibrosis
  6. description
    Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
    id
    BG005
    title
    Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Myelofibrosis
  7. description
    Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
    id
    BG006
    title
    Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Advanced Systemic Mastocytosis
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. comment
          Insufficient number of participants to determine standard deviation.
          group Id
          BG000
          spread
          NA
          value
          42.0
        2. group Id
          BG001
          spread
          4.24
          value
          66.0
        3. group Id
          BG002
          spread
          8.88
          value
          69.1
        4. group Id
          BG003
          spread
          4.95
          value
          65.5
        5. comment
          Insufficient number of participants to determine standard deviation.
          group Id
          BG004
          spread
          NA
          value
          81.0
        6. group Id
          BG005
          spread
          7.97
          value
          70.4
        7. comment
          Insufficient number of participants to determine standard deviation.
          group Id
          BG006
          spread
          NA
          value
          63
        8. group Id
          BG007
          spread
          8.81
          value
          69.3
    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
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          16
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          29
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          29
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          20
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          53
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          10
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          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
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          32
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          25
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          62
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          9
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          29
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          23
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          57
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          16
      title
      2
    description
    ECOG Performance Status is a scale that measures how cancer affects a participant's daily living activities. The scale ranges from 0 (normal activity) to 5 (dead). 0 = Fully active without restriction; 1 = Restricted in physically strenuous activity; 2 = Ambulatory, capable of all selfcare; 3 = Capable of limited selfcare; 4 = Completely disabled; 5 = Dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
population Description
Safety Population: All participants who received at least 1 dose of study drug.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      1
    2. group Id
      BG001
      value
      2
    3. group Id
      BG002
      value
      39
    4. group Id
      BG003
      value
      2
    5. group Id
      BG004
      value
      1
    6. group Id
      BG005
      value
      36
    7. group Id
      BG006
      value
      1
    8. group Id
      BG007
      value
      82
    units
    Participants
groups
  1. description
    Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
    id
    BG000
    title
    Dose Level 1 -Tagraxofusp - 7 µg/kg/Day - Chronic Myelomonocytic Leukemia
  2. description
    Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
    id
    BG001
    title
    Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Chronic Myelomonocytic Leukemia
  3. description
    Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
    id
    BG002
    title
    Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Chronic Myelomonocytic Leukemia
  4. description
    Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
    id
    BG003
    title
    Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Myelofibrosis
  5. description
    Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
    id
    BG004
    title
    Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Myelofibrosis
  6. description
    Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
    id
    BG005
    title
    Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Myelofibrosis
  7. description
    Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
    id
    BG006
    title
    Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Advanced Systemic Mastocytosis
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. comment
          Insufficient number of participants to determine standard deviation.
          group Id
          BG000
          spread
          NA
          value
          42.0
        2. group Id
          BG001
          spread
          4.24
          value
          66.0
        3. group Id
          BG002
          spread
          8.88
          value
          69.1
        4. group Id
          BG003
          spread
          4.95
          value
          65.5
        5. comment
          Insufficient number of participants to determine standard deviation.
          group Id
          BG004
          spread
          NA
          value
          81.0
        6. group Id
          BG005
          spread
          7.97
          value
          70.4
        7. comment
          Insufficient number of participants to determine standard deviation.
          group Id
          BG006
          spread
          NA
          value
          63
        8. group Id
          BG007
          spread
          8.81
          value
          69.3
    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
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          16
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          29
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          29
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          20
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          53
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          10
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          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
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          32
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          25
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          62
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          4
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          9
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          29
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          23
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          57
      title
      1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          16
      title
      2
    description
    ECOG Performance Status is a scale that measures how cancer affects a participant's daily living activities. The scale ranges from 0 (normal activity) to 5 (dead). 0 = Fully active without restriction; 1 = Restricted in physically strenuous activity; 2 = Ambulatory, capable of all selfcare; 3 = Capable of limited selfcare; 4 = Completely disabled; 5 = Dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
population Description
Safety Population: All participants who received at least 1 dose of study drug.

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Preserved source evidence · Not medical advice