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NCT02566265 · BASELINE

Baseline characteristics

Study of High-dose Influenza Vaccine Efficacy by Repeated Dosing IN Gammopathy Patients · Source last updated 2019-01-30

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
      81
    2. group Id
      BG001
      value
      41
    3. group Id
      BG002
      value
      122
    units
    Participants
groups
  1. description
    Fluzone High dose vaccine administered at Day 0. Fluzone High dose vaccine administered as a booster after 30 days from the initial vaccine. Fluzone High Dose Vaccine
    id
    BG000
    title
    Fluzone High Dose Vaccine Then Fluzone High Dose Booster
  2. description
    Fluzone High-Dose if age greater than or equal to 65 or Standard dose influenza vaccine if age less than 65 at day 0. Placebo administered 30 days after the initial vaccine. Standard of care/Placebo
    id
    BG001
    title
    Standard of Care
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          42
          upper Limit
          90
          value
          67
        2. group Id
          BG001
          lower Limit
          37
          upper Limit
          89
          value
          66
        3. group Id
          BG002
          lower Limit
          37
          upper Limit
          90
          value
          67
      denoms
      1. counts
        1. group Id
          BG000
          value
          81
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          122
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          60
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          62
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          81
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          122
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG002
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          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
          81
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          122
      denoms
      1. counts
        1. group Id
          BG000
          value
          81
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          122
        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
          53
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          81
        title
        Multiple Myeloma
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
        title
        WM
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Other
      4. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          9
        title
        Asymptomatic Myeloma
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        title
        Asymptomatic WM
      6. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          15
        title
        MGUS
      denoms
      1. counts
        1. group Id
          BG000
          value
          81
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          122
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Detailed Diagnosis
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          96
        title
        Advanced
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          26
        title
        Early
      denoms
      1. counts
        1. group Id
          BG000
          value
          81
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          122
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Stage
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      81
    2. group Id
      BG001
      value
      41
    3. group Id
      BG002
      value
      122
    units
    Participants
groups
  1. description
    Fluzone High dose vaccine administered at Day 0. Fluzone High dose vaccine administered as a booster after 30 days from the initial vaccine. Fluzone High Dose Vaccine
    id
    BG000
    title
    Fluzone High Dose Vaccine Then Fluzone High Dose Booster
  2. description
    Fluzone High-Dose if age greater than or equal to 65 or Standard dose influenza vaccine if age less than 65 at day 0. Placebo administered 30 days after the initial vaccine. Standard of care/Placebo
    id
    BG001
    title
    Standard of Care
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          42
          upper Limit
          90
          value
          67
        2. group Id
          BG001
          lower Limit
          37
          upper Limit
          89
          value
          66
        3. group Id
          BG002
          lower Limit
          37
          upper Limit
          90
          value
          67
      denoms
      1. counts
        1. group Id
          BG000
          value
          81
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          122
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          60
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          62
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          81
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          122
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG002
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          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
          81
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          122
      denoms
      1. counts
        1. group Id
          BG000
          value
          81
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          122
        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
          53
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          81
        title
        Multiple Myeloma
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
        title
        WM
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Other
      4. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          9
        title
        Asymptomatic Myeloma
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        title
        Asymptomatic WM
      6. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          15
        title
        MGUS
      denoms
      1. counts
        1. group Id
          BG000
          value
          81
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          122
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Detailed Diagnosis
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          96
        title
        Advanced
      2. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          26
        title
        Early
      denoms
      1. counts
        1. group Id
          BG000
          value
          81
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          122
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Stage
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice