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NCT00267865 · BASELINE

Baseline characteristics

Chemotherapy and HAART to Treat AIDS-related Primary Brain Lymphoma · Source last updated 2020-06-01

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
      12
    units
    Participants
groups
  1. description
    Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy. Methotrexate: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour. Rituximab: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
    id
    BG000
    title
    Rituximab, High-Dose Methotrexate & Leucovorin Treatment
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          12
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          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
          10.01
          value
          33.74
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          9
        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
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          8
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        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
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        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
          12
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          5
          upper Limit
          29
          value
          22
    description
    The MMSE is scored out of a maximum of 30 points. A score of \>25 is considered normal, with scores \<25 indicating different levels of cognitive impairment: mild (21-24) moderate (10-20), and severe (0-10).
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Median Baseline Mini Mental State Exam (MMSE) Score
    unit Of Measure
    score on a scale
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          3
          value
          2
    description
    ECOG Scale: 0 is fully active and able to carry on activities of daily living without restriction; 1 is restricted in physically strenuous activity but ambulatory, can perform light housework; 2 is ambulatory and able to perform self care but unable to carry out work activities; 3 is capable of limited self care and confined to bed or chair more than 50% of waking hours; 4 is completely disabled, unable to perform selfcare, and confined to bed or chair; and 5 is dead.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Median Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    scores on a scale
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          409
          value
          16
    description
    Primary central nervous system lymphoma (PCNSL). PCNSL was biopsy confirmed or made by fludeoxyglucose positron emission tomography/cerebral spinal fluid Epstein Barr-Virus (EBV) viral load criteria.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Baseline Cluster of Differentiation (CD4) T Cell Count at PCNSL Diagnosis
    unit Of Measure
    cells/µL
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      12
    units
    Participants
groups
  1. description
    Induction treatment cycles with rituximab, high-dose methotrexate and leucovorin will be administered every 2 weeks for 6 cycles. Two additional consolidation cycles of high-dose methotrexate without rituximab will be administered at 4 weeks and 8 weeks following completion of the combined therapy. Methotrexate: 6000 mg/m\^2 will be administered by intravenous infusion over 4 hours after confirming that the recipient patients urine pH is within the range greater than or equal to 7 to less than or equal to 8, and urine output is greater than or equal to 100 mL/hour. Rituximab: 375 mg/m\^2 intravenous (IV) day 1 of each cycle prior to administration of high-dose methotrexate Leucovorin: Leucovorin calcium doses will be administered orally or by short intravenous (IV) infusion over 15 minutes
    id
    BG000
    title
    Rituximab, High-Dose Methotrexate & Leucovorin Treatment
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          12
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          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
          10.01
          value
          33.74
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          9
        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
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          8
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        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
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        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
          12
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          5
          upper Limit
          29
          value
          22
    description
    The MMSE is scored out of a maximum of 30 points. A score of \>25 is considered normal, with scores \<25 indicating different levels of cognitive impairment: mild (21-24) moderate (10-20), and severe (0-10).
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Median Baseline Mini Mental State Exam (MMSE) Score
    unit Of Measure
    score on a scale
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1
          upper Limit
          3
          value
          2
    description
    ECOG Scale: 0 is fully active and able to carry on activities of daily living without restriction; 1 is restricted in physically strenuous activity but ambulatory, can perform light housework; 2 is ambulatory and able to perform self care but unable to carry out work activities; 3 is capable of limited self care and confined to bed or chair more than 50% of waking hours; 4 is completely disabled, unable to perform selfcare, and confined to bed or chair; and 5 is dead.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Median Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    scores on a scale
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          409
          value
          16
    description
    Primary central nervous system lymphoma (PCNSL). PCNSL was biopsy confirmed or made by fludeoxyglucose positron emission tomography/cerebral spinal fluid Epstein Barr-Virus (EBV) viral load criteria.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Baseline Cluster of Differentiation (CD4) T Cell Count at PCNSL Diagnosis
    unit Of Measure
    cells/µL

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Preserved source evidence · Not medical advice