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NCT00627393 · BASELINE

Baseline characteristics

Safety and Effectiveness of Granulocyte Transfusions in Resolving Infection in People With Neutropenia (The RING Study) · Source last updated 2015-04-17

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
      58
    2. group Id
      BG001
      value
      56
    3. group Id
      BG002
      value
      114
    units
    Participants
groups
  1. description
    Received antimicrobial therapy alone.
    id
    BG000
    title
    Control Arm
  2. description
    Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
    id
    BG001
    title
    Granulocyte Arm
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          71
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          33
        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
          19.8
          value
          49.1
        2. group Id
          BG001
          spread
          16.3
          value
          54.8
        3. group Id
          BG002
          spread
          18.3
          value
          51.9
    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
          28
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          51
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          63
        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
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          84
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          24
        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
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          79
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          22
        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
          spread
          23.8
          value
          76.0
        2. group Id
          BG001
          spread
          20.6
          value
          78.7
        3. group Id
          BG002
          spread
          22.2
          value
          77.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          87
      title
      Chemotherapy only
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          10
      title
      Infection
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          17
      title
      HST (or preparation for HST)
    param Type
    NUMBER
    title
    Cause of neutropenia
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.091
          value
          0.046
        2. group Id
          BG001
          spread
          0.096
          value
          0.058
        3. group Id
          BG002
          spread
          0.094
          value
          0.052
    description
    ANC = Absolute neutrophil count. Subjects with ANC less than 500/mm\^3 were considered to have severe neutropenia.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    ANC prior to randomization
    unit Of Measure
    x10^9 cells/L
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          37
      title
      0 to 2
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          77
      title
      3 to 5
    description
    The Zubrod scoring system ranks patients on their functionality on a scale from 0-5. Zubrod score category "0 to 2" represents asymptomatic, symptomatic but completely ambulatory, or symptomatic and 50% in bed during the day. Zubrod score category "3 to 5" represents symptomatic and more than 50% in bed (but not bedbound), being bedbound or completely disabled, or being moribund.
    param Type
    NUMBER
    title
    Zubrod score
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          33
      title
      Bacteremia only
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          28
      title
      Tissue bacterial infection
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          13
      title
      Fungemia only
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          40
      title
      Tissue fungal infection
    param Type
    NUMBER
    title
    Infection type
    unit Of Measure
    participants
population Description
All randomized subjects.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      58
    2. group Id
      BG001
      value
      56
    3. group Id
      BG002
      value
      114
    units
    Participants
groups
  1. description
    Received antimicrobial therapy alone.
    id
    BG000
    title
    Control Arm
  2. description
    Received G-CSF/dexamethasone-mobilized granulocyte transfusions in addition to antimicrobial therapy.
    id
    BG001
    title
    Granulocyte Arm
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          71
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          33
        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
          19.8
          value
          49.1
        2. group Id
          BG001
          spread
          16.3
          value
          54.8
        3. group Id
          BG002
          spread
          18.3
          value
          51.9
    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
          28
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          51
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          63
        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
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          84
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          24
        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
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          79
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          22
        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
          spread
          23.8
          value
          76.0
        2. group Id
          BG001
          spread
          20.6
          value
          78.7
        3. group Id
          BG002
          spread
          22.2
          value
          77.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          87
      title
      Chemotherapy only
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          10
      title
      Infection
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          17
      title
      HST (or preparation for HST)
    param Type
    NUMBER
    title
    Cause of neutropenia
    unit Of Measure
    participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.091
          value
          0.046
        2. group Id
          BG001
          spread
          0.096
          value
          0.058
        3. group Id
          BG002
          spread
          0.094
          value
          0.052
    description
    ANC = Absolute neutrophil count. Subjects with ANC less than 500/mm\^3 were considered to have severe neutropenia.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    ANC prior to randomization
    unit Of Measure
    x10^9 cells/L
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          37
      title
      0 to 2
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          77
      title
      3 to 5
    description
    The Zubrod scoring system ranks patients on their functionality on a scale from 0-5. Zubrod score category "0 to 2" represents asymptomatic, symptomatic but completely ambulatory, or symptomatic and 50% in bed during the day. Zubrod score category "3 to 5" represents symptomatic and more than 50% in bed (but not bedbound), being bedbound or completely disabled, or being moribund.
    param Type
    NUMBER
    title
    Zubrod score
    unit Of Measure
    participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          33
      title
      Bacteremia only
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          28
      title
      Tissue bacterial infection
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          13
      title
      Fungemia only
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          40
      title
      Tissue fungal infection
    param Type
    NUMBER
    title
    Infection type
    unit Of Measure
    participants
population Description
All randomized subjects.

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