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NCT00248534 · BASELINE

Baseline characteristics

Rituximab, Temozolomide, and Methylprednisolone in Treating Patients With Recurrent Primary CNS Non-Hodgkin's Lymphoma · Source last updated 2018-09-04

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
      16
    units
    Participants
groups
  1. description
    IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks. Induction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide \[TMZ\] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression rituximab: given IV days 1,8, 15 and 22 methylprednisolone: 2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles) temozolomide: Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles
    id
    BG000
    title
    IV Rituximab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          42
          upper Limit
          79
          value
          63
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Customized
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        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
          lower Limit
          60
          upper Limit
          100
          value
          90
    description
    Higher score better 100 normal no complaints/disease 90 capable normal activity few symptoms/disease 80 normal activity, some difficulty some symptoms/signs 70 caring for self not capable normal activity/work 60 requiring some help can take care of most personal requirements 50 requires help often requires frequent medical care 40 disabled requires special care/help 30 severely disabled hospital admission indicated but no risk of death 20 very ill urgently requiring admission requires supportive measures/treatment 10 moribund rapidly progressive fatal disease processes 0 death
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Karnofsky Performance Status Scale
    unit Of Measure
    units on a scale
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      16
    units
    Participants
groups
  1. description
    IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks. Induction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide \[TMZ\] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression rituximab: given IV days 1,8, 15 and 22 methylprednisolone: 2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles) temozolomide: Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles
    id
    BG000
    title
    IV Rituximab
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          42
          upper Limit
          79
          value
          63
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Customized
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        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
          lower Limit
          60
          upper Limit
          100
          value
          90
    description
    Higher score better 100 normal no complaints/disease 90 capable normal activity few symptoms/disease 80 normal activity, some difficulty some symptoms/signs 70 caring for self not capable normal activity/work 60 requiring some help can take care of most personal requirements 50 requires help often requires frequent medical care 40 disabled requires special care/help 30 severely disabled hospital admission indicated but no risk of death 20 very ill urgently requiring admission requires supportive measures/treatment 10 moribund rapidly progressive fatal disease processes 0 death
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Karnofsky Performance Status Scale
    unit Of Measure
    units on a scale

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Preserved source evidence · Not medical advice