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NCT01408563 · BASELINE

Baseline characteristics

Reduced Intensity Double Umbilical Cord Blood Transplantation · Source last updated 2019-01-23

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
      31
    units
    Participants
groups
  1. description
    All patients receive same therapy Fludarabine: 30 mg/m2/day IV x 6 days Melphalan: 100 mg/m2/day IV x 1 day Total Body Radiation: 200 cGy on Day 0 Cord Blood: 2 cord blood units IV
    id
    BG000
    title
    Fludarabine/Melphalan/TBI
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          21
          upper Limit
          68
          value
          57
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        units
        Participants
    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
          9
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          22
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. denoms
      1. counts
        1. group Id
          BG000
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          31
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        units
        Participants
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          19
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        2
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        units
        Participants
    description
    Eastern Cooperative Oncology Group (ECOG) Performance Status: * 0 - Asymptomatic (Fully active, able to carry on all predisease activities without restriction) * 1 - Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work) * 2 - Symptomatic, \<50% in bed during the day (Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        Acute Lymphoblastic Leukemia (ALL)
      2. measurements
        1. group Id
          BG000
          value
          11
        title
        Acute Myeloid Leukemia (AML)
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Hodgkin's Disease (HD)
      4. measurements
        1. group Id
          BG000
          value
          8
        title
        Myelodysplastic Syndromes (MDS)
      5. measurements
        1. group Id
          BG000
          value
          2
        title
        Myeloproliferative Disorder (MPD)
      6. measurements
        1. group Id
          BG000
          value
          7
        title
        Non-Hodgkin Lymphoma (NHL)
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease
    unit Of Measure
    Participants
population Description
The two participants found to be ineligible after being consented and registered were excluded from the analysis.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      31
    units
    Participants
groups
  1. description
    All patients receive same therapy Fludarabine: 30 mg/m2/day IV x 6 days Melphalan: 100 mg/m2/day IV x 1 day Total Body Radiation: 200 cGy on Day 0 Cord Blood: 2 cord blood units IV
    id
    BG000
    title
    Fludarabine/Melphalan/TBI
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          21
          upper Limit
          68
          value
          57
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        units
        Participants
    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
          9
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          22
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. denoms
      1. counts
        1. group Id
          BG000
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          31
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        units
        Participants
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          19
        title
        1
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        2
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        units
        Participants
    description
    Eastern Cooperative Oncology Group (ECOG) Performance Status: * 0 - Asymptomatic (Fully active, able to carry on all predisease activities without restriction) * 1 - Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work) * 2 - Symptomatic, \<50% in bed during the day (Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        Acute Lymphoblastic Leukemia (ALL)
      2. measurements
        1. group Id
          BG000
          value
          11
        title
        Acute Myeloid Leukemia (AML)
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Hodgkin's Disease (HD)
      4. measurements
        1. group Id
          BG000
          value
          8
        title
        Myelodysplastic Syndromes (MDS)
      5. measurements
        1. group Id
          BG000
          value
          2
        title
        Myeloproliferative Disorder (MPD)
      6. measurements
        1. group Id
          BG000
          value
          7
        title
        Non-Hodgkin Lymphoma (NHL)
      denoms
      1. counts
        1. group Id
          BG000
          value
          31
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease
    unit Of Measure
    Participants
population Description
The two participants found to be ineligible after being consented and registered were excluded from the analysis.

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

Preserved source evidence · Not medical advice