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NCT00586924 · BASELINE

Baseline characteristics

A Phase I, Multicenter Dose Escalation Study in Patients With Hairy Cell Leukemia · Source last updated 2019-04-02

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
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      3
    5. group Id
      BG004
      value
      4
    6. group Id
      BG005
      value
      33
    7. group Id
      BG006
      value
      49
    units
    Participants
groups
  1. description
    Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    id
    BG000
    title
    5 mcg/kg
  2. description
    Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    id
    BG001
    title
    10 mcg/kg
  3. description
    Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    id
    BG002
    title
    20 mcg/kg
  4. description
    Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    id
    BG003
    title
    30 mcg/kg
  5. description
    Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    id
    BG004
    title
    40 mcg/kg
  6. description
    Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    id
    BG005
    title
    50 mcg/kg
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.2
          value
          56.3
        2. group Id
          BG001
          spread
          6.1
          value
          54.3
        3. group Id
          BG002
          spread
          3.1
          value
          56.3
        4. group Id
          BG003
          spread
          4.0
          value
          58.3
        5. group Id
          BG004
          spread
          11.1
          value
          61.8
        6. group Id
          BG005
          spread
          9.0
          value
          55.8
        7. group Id
          BG006
          spread
          8.7
          value
          56.4
      title
      Years
    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
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          8
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          28
        7. group Id
          BG006
          value
          41
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Safety population: included all participants who received any treatment of moxetumomab pasudotox
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      3
    5. group Id
      BG004
      value
      4
    6. group Id
      BG005
      value
      33
    7. group Id
      BG006
      value
      49
    units
    Participants
groups
  1. description
    Participants received IV 5 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued until complete response (CR), progressive disease (PD), initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    id
    BG000
    title
    5 mcg/kg
  2. description
    Participants received IV 10 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    id
    BG001
    title
    10 mcg/kg
  3. description
    Participants received IV 20 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    id
    BG002
    title
    20 mcg/kg
  4. description
    Participants received IV 30 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    id
    BG003
    title
    30 mcg/kg
  5. description
    Participants received IV 40 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    id
    BG004
    title
    40 mcg/kg
  6. description
    Participants received IV 50 mcg/kg moxetumomab pasudotox on Days 1, 3, and 5 of every 28-day cycle and continued cycles of therapy until CR, PD, initiation of alternative anticancer therapy, unacceptable toxicity, development of neutralizing antibodies, or another reason to discontinue therapy.
    id
    BG005
    title
    50 mcg/kg
  7. description
    Total of all reporting groups
    id
    BG006
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.2
          value
          56.3
        2. group Id
          BG001
          spread
          6.1
          value
          54.3
        3. group Id
          BG002
          spread
          3.1
          value
          56.3
        4. group Id
          BG003
          spread
          4.0
          value
          58.3
        5. group Id
          BG004
          spread
          11.1
          value
          61.8
        6. group Id
          BG005
          spread
          9.0
          value
          55.8
        7. group Id
          BG006
          spread
          8.7
          value
          56.4
      title
      Years
    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
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          8
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          28
        7. group Id
          BG006
          value
          41
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Safety population: included all participants who received any treatment of moxetumomab pasudotox

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

Preserved source evidence · Not medical advice