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NCT01307579 · BASELINE

Baseline characteristics

Caspofungin Versus Fluconazole in Preventing Invasive Fungal Infections (IFI) in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia · Source last updated 2021-03-30

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
      257
    2. group Id
      BG001
      value
      260
    3. group Id
      BG002
      value
      517
    units
    Participants
groups
  1. description
    Patients receive caspofungin acetate IV over one hour QD beginning within 24-72 hours following the last dose of chemotherapy for each course. and continuing until ANC \> 100-500/uL following the nadir or the next chemotherapy course begins. Caspofungin Acetate: Given IV Laboratory Biomarker Analysis: Correlative studies
    id
    BG000
    title
    Arm I (Caspofungin Acetate)
  2. description
    Patients receive fluconazole IV over 1-2 hours or PO QD beginning within 24-72 hours following the last dose of chemotherapy for each course. Fluconazole: Given IV or PO Laboratory Biomarker Analysis: Correlative studies
    id
    BG001
    title
    Arm II (Fluconazole)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          235
        2. group Id
          BG001
          value
          242
        3. group Id
          BG002
          value
          477
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          40
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.5
          value
          9.2
        2. group Id
          BG001
          spread
          6.0
          value
          8.8
        3. group Id
          BG002
          spread
          6.3
          value
          9.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          114
        2. group Id
          BG001
          value
          114
        3. group Id
          BG002
          value
          228
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          143
        2. group Id
          BG001
          value
          146
        3. group Id
          BG002
          value
          289
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          93
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          206
        2. group Id
          BG001
          value
          203
        3. group Id
          BG002
          value
          409
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          15
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          38
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          61
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          181
        2. group Id
          BG001
          value
          179
        3. group Id
          BG002
          value
          360
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          53
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          234
        2. group Id
          BG001
          value
          227
        3. group Id
          BG002
          value
          461
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          55
      title
      Canada
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      United Arab Emirates
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      257
    2. group Id
      BG001
      value
      260
    3. group Id
      BG002
      value
      517
    units
    Participants
groups
  1. description
    Patients receive caspofungin acetate IV over one hour QD beginning within 24-72 hours following the last dose of chemotherapy for each course. and continuing until ANC \> 100-500/uL following the nadir or the next chemotherapy course begins. Caspofungin Acetate: Given IV Laboratory Biomarker Analysis: Correlative studies
    id
    BG000
    title
    Arm I (Caspofungin Acetate)
  2. description
    Patients receive fluconazole IV over 1-2 hours or PO QD beginning within 24-72 hours following the last dose of chemotherapy for each course. Fluconazole: Given IV or PO Laboratory Biomarker Analysis: Correlative studies
    id
    BG001
    title
    Arm II (Fluconazole)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          235
        2. group Id
          BG001
          value
          242
        3. group Id
          BG002
          value
          477
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          40
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.5
          value
          9.2
        2. group Id
          BG001
          spread
          6.0
          value
          8.8
        3. group Id
          BG002
          spread
          6.3
          value
          9.0
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    Years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          114
        2. group Id
          BG001
          value
          114
        3. group Id
          BG002
          value
          228
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          143
        2. group Id
          BG001
          value
          146
        3. group Id
          BG002
          value
          289
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          93
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          206
        2. group Id
          BG001
          value
          203
        3. group Id
          BG002
          value
          409
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          15
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          38
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          61
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          181
        2. group Id
          BG001
          value
          179
        3. group Id
          BG002
          value
          360
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          53
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          234
        2. group Id
          BG001
          value
          227
        3. group Id
          BG002
          value
          461
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          55
      title
      Canada
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      United Arab Emirates
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice