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NCT01101880 · BASELINE

Baseline characteristics

Clofarabine, Cytarabine, and Filgrastim in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia, Advanced Myelodysplastic Syndrome, and/or Advanced Myeloproliferative Neoplasm · Source last updated 2017-10-19

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
      50
    units
    Participants
groups
  1. description
    INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days. CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days. Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity. filgrastim: Given SC clofarabine: Given IV cytarabine: Given IV
    id
    BG000
    title
    Treatment (Chemotherapy and Colony Stimulating Factor)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          22
          upper Limit
          64
          value
          53
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          27
        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
          4
        title
        Favorable
      2. measurements
        1. group Id
          BG000
          value
          32
        title
        Intermediate
      3. measurements
        1. group Id
          BG000
          value
          13
        title
        Unfavorable
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Indeterminate
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cytogenetic Risk Factor
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Antecedent hematological disorder (AHD)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
    description
    Number of participants with a FLT3 ITD mutation
    param Type
    COUNT_OF_PARTICIPANTS
    title
    FLT3 ITD mutation status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.8
          upper Limit
          761.3
          value
          12
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    WBC
    unit Of Measure
    cells x 10^9/L
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          100
          value
          16
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Peripheral Blast
    unit Of Measure
    percent of white blood cells
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      50
    units
    Participants
groups
  1. description
    INDUCTION THERAPY: Patients receive filgrastim SC daily beginning the day prior to chemotherapy and continuing until blood counts recover. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 5 days. CONSOLIDATION THERAPY: Patients receive filgrastim SC daily for 5 days beginning the day prior to chemotherapy. Patients receive clofarabine IV over 1 hour followed by cytarabine IV over 2 hours daily for 4 days. Treatment with induction therapy may continue for up to 2 courses and treatment with consolidation therapy may continue for up to 3 courses in the absence of disease progression or unacceptable toxicity. filgrastim: Given SC clofarabine: Given IV cytarabine: Given IV
    id
    BG000
    title
    Treatment (Chemotherapy and Colony Stimulating Factor)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          22
          upper Limit
          64
          value
          53
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          27
        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
          4
        title
        Favorable
      2. measurements
        1. group Id
          BG000
          value
          32
        title
        Intermediate
      3. measurements
        1. group Id
          BG000
          value
          13
        title
        Unfavorable
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Indeterminate
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cytogenetic Risk Factor
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          23
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Antecedent hematological disorder (AHD)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
    description
    Number of participants with a FLT3 ITD mutation
    param Type
    COUNT_OF_PARTICIPANTS
    title
    FLT3 ITD mutation status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.8
          upper Limit
          761.3
          value
          12
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    WBC
    unit Of Measure
    cells x 10^9/L
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          100
          value
          16
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Peripheral Blast
    unit Of Measure
    percent of white blood cells

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Preserved source evidence · Not medical advice