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NCT02919670 · BASELINE

Baseline characteristics

A Study Evaluating a Proprietary Amino Acid Mixture (Enterade®) in Patients Receiving High-Dose Melphalan Conditioning Followed by Autologous Stem Cell Transplantation for Multiple Myeloma and Non-Hodgkin Lymphoma · Source last updated 2023-03-16

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
      49
    2. group Id
      BG001
      value
      50
    3. group Id
      BG002
      value
      99
    units
    Participants
groups
  1. description
    * Two 8 oz. bottles of Enterade will be administered daily * Enterade will be given orally from admission until day +14 or until discharge * Standard Supportive Care will be administered according to institution's practice Enterade Standard Supportive Care
    id
    BG000
    title
    Enterade and Standard Supportive Care
  2. description
    * Two 8 oz. bottles of Placebo will be administered daily * Placebo will be given orally from admission until day +14 or until discharge * Standard Supportive Care will be administered according to institution's practice Placebo Standard Supportive Care
    id
    BG001
    title
    Placebo and Standard Supportive Care
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          88
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
        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
          lower Limit
          25
          upper Limit
          74
          value
          61
        2. group Id
          BG001
          lower Limit
          40
          upper Limit
          77
          value
          59
        3. group Id
          BG002
          lower Limit
          25
          upper Limit
          77
          value
          60
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          25
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          74
        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
          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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          89
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          99
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          99
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Count of participants
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      49
    2. group Id
      BG001
      value
      50
    3. group Id
      BG002
      value
      99
    units
    Participants
groups
  1. description
    * Two 8 oz. bottles of Enterade will be administered daily * Enterade will be given orally from admission until day +14 or until discharge * Standard Supportive Care will be administered according to institution's practice Enterade Standard Supportive Care
    id
    BG000
    title
    Enterade and Standard Supportive Care
  2. description
    * Two 8 oz. bottles of Placebo will be administered daily * Placebo will be given orally from admission until day +14 or until discharge * Standard Supportive Care will be administered according to institution's practice Placebo Standard Supportive Care
    id
    BG001
    title
    Placebo and Standard Supportive Care
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          88
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          11
        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
          lower Limit
          25
          upper Limit
          74
          value
          61
        2. group Id
          BG001
          lower Limit
          40
          upper Limit
          77
          value
          59
        3. group Id
          BG002
          lower Limit
          25
          upper Limit
          77
          value
          60
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          25
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          74
        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
          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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          7
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          89
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          99
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          99
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Count of participants
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice