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NCT02113982 · BASELINE

Baseline characteristics

Tagraxofusp in Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm or Acute Myeloid Leukemia · Source last updated 2024-08-01

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
      6
    2. group Id
      BG001
      value
      13
    3. group Id
      BG002
      value
      13
    4. group Id
      BG003
      value
      36
    5. group Id
      BG004
      value
      3
    6. group Id
      BG005
      value
      10
    7. group Id
      BG006
      value
      6
    8. group Id
      BG007
      value
      14
    9. group Id
      BG008
      value
      35
    10. group Id
      BG009
      value
      136
    units
    Participants
groups
  1. description
    Dose Escalation, 7 or 12 µg/kg/day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    BG000
    title
    First-line BPDCN- Stage 1
  2. description
    Administration of 12 µg/kg/day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    BG001
    title
    First-line BPDCN - Stage 2
  3. description
    Administration of 12 µg/kg/day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    BG002
    title
    First-line BPDCN - Stage 3
  4. description
    Administration of 12 µg/kg/day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    BG003
    title
    First-line BPDCN - Stage 4
  5. description
    Dose Escalation, 12 µg/kg/ day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    BG004
    title
    R/R BPDCN - Stage 1
  6. description
    Administration of 12 µg/kg/day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    BG005
    title
    R/R BPDCN - Stage 2
  7. description
    Administration of 12 µg/kg/day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    BG006
    title
    R/R BPDCN - Stage 4
  8. description
    Dose Escalation 7, 9,12 or 16 µg/kg/ day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    BG007
    title
    AML - Stage 1
  9. description
    Administration of 12 µg/kg/ day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    BG008
    title
    AML - Stage 2
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.49
          value
          67
        2. group Id
          BG001
          spread
          17.72
          value
          62.5
        3. group Id
          BG002
          spread
          17.15
          value
          61.7
        4. group Id
          BG003
          spread
          14.71
          value
          64.1
        5. group Id
          BG004
          spread
          7.94
          value
          72
        6. group Id
          BG005
          spread
          9.31
          value
          69.7
        7. group Id
          BG006
          spread
          15.32
          value
          67.5
        8. group Id
          BG007
          spread
          11.17
          value
          58.6
        9. group Id
          BG008
          spread
          16.01
          value
          61.2
        10. group Id
          BG009
          spread
          14.64
          value
          63.4
    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
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          13
        10. group Id
          BG009
          value
          36
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          29
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          22
        10. group Id
          BG009
          value
          100
        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
          5
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          30
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          12
        9. group Id
          BG008
          value
          31
        10. group Id
          BG009
          value
          120
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          16
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          51
      title
      ECOG 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          26
        10. group Id
          BG009
          value
          78
      title
      ECOG 1
    3. 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
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          5
      title
      ECOG 2
    4. 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
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          2
      title
      Missing
    description
    Grade 0 Able to carry out all normal activities without restriction. Grade 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. Grade 2 Ambulatory and capable of all self-care but unable to carry out any work activities: up and about more than 50% of waking hours. Grade 3 Capable of limited self-care; confined to bed or chair more than 50% of waking hours. Grade 4 Completely disabled; cannot carry on self-care; totally confined to bed or chair.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status Scale
    unit Of Measure
    Participants
population Description
modified ITT (mITT): all patients with blastic plasmacytoid dendritic cell neoplasm (first-line or relapsed/refractory) and acute myeloid leukemia who were eligible based on the screening criteria and who received at least 1 dose of tagraxofusp, excluding 2 patients who withdrew from study before first response assessment. Total mITT=136. Baseline characteristics data collected by disease and study stage only.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      6
    2. group Id
      BG001
      value
      13
    3. group Id
      BG002
      value
      13
    4. group Id
      BG003
      value
      36
    5. group Id
      BG004
      value
      3
    6. group Id
      BG005
      value
      10
    7. group Id
      BG006
      value
      6
    8. group Id
      BG007
      value
      14
    9. group Id
      BG008
      value
      35
    10. group Id
      BG009
      value
      136
    units
    Participants
groups
  1. description
    Dose Escalation, 7 or 12 µg/kg/day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    BG000
    title
    First-line BPDCN- Stage 1
  2. description
    Administration of 12 µg/kg/day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    BG001
    title
    First-line BPDCN - Stage 2
  3. description
    Administration of 12 µg/kg/day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    BG002
    title
    First-line BPDCN - Stage 3
  4. description
    Administration of 12 µg/kg/day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    BG003
    title
    First-line BPDCN - Stage 4
  5. description
    Dose Escalation, 12 µg/kg/ day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    BG004
    title
    R/R BPDCN - Stage 1
  6. description
    Administration of 12 µg/kg/day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    BG005
    title
    R/R BPDCN - Stage 2
  7. description
    Administration of 12 µg/kg/day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    BG006
    title
    R/R BPDCN - Stage 4
  8. description
    Dose Escalation 7, 9,12 or 16 µg/kg/ day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    BG007
    title
    AML - Stage 1
  9. description
    Administration of 12 µg/kg/ day of Tagraxofusp as IV over 15 minutes for up to 5 consecutive days of a 21-day cycle
    id
    BG008
    title
    AML - Stage 2
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.49
          value
          67
        2. group Id
          BG001
          spread
          17.72
          value
          62.5
        3. group Id
          BG002
          spread
          17.15
          value
          61.7
        4. group Id
          BG003
          spread
          14.71
          value
          64.1
        5. group Id
          BG004
          spread
          7.94
          value
          72
        6. group Id
          BG005
          spread
          9.31
          value
          69.7
        7. group Id
          BG006
          spread
          15.32
          value
          67.5
        8. group Id
          BG007
          spread
          11.17
          value
          58.6
        9. group Id
          BG008
          spread
          16.01
          value
          61.2
        10. group Id
          BG009
          spread
          14.64
          value
          63.4
    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
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          13
        10. group Id
          BG009
          value
          36
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          29
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          22
        10. group Id
          BG009
          value
          100
        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
          5
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          30
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          12
        9. group Id
          BG008
          value
          31
        10. group Id
          BG009
          value
          120
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          16
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          51
      title
      ECOG 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          26
        10. group Id
          BG009
          value
          78
      title
      ECOG 1
    3. 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
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          5
      title
      ECOG 2
    4. 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
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          2
      title
      Missing
    description
    Grade 0 Able to carry out all normal activities without restriction. Grade 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. Grade 2 Ambulatory and capable of all self-care but unable to carry out any work activities: up and about more than 50% of waking hours. Grade 3 Capable of limited self-care; confined to bed or chair more than 50% of waking hours. Grade 4 Completely disabled; cannot carry on self-care; totally confined to bed or chair.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Performance Status Scale
    unit Of Measure
    Participants
population Description
modified ITT (mITT): all patients with blastic plasmacytoid dendritic cell neoplasm (first-line or relapsed/refractory) and acute myeloid leukemia who were eligible based on the screening criteria and who received at least 1 dose of tagraxofusp, excluding 2 patients who withdrew from study before first response assessment. Total mITT=136. Baseline characteristics data collected by disease and study stage only.

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Preserved source evidence · Not medical advice