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NCT01305200 · BASELINE

Baseline characteristics

Supersaturated Calcium Phosphate Rinse in Preventing Oral Mucositis in Young Patients Undergoing Autologous or Donor Stem Cell Transplant · Source last updated 2019-09-17

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
      111
    2. group Id
      BG001
      value
      112
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      226
    units
    Participants
groups
  1. description
    Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. placebo: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies
    id
    BG000
    title
    Arm I (Placebo)
  2. description
    Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. supersaturated calcium phosphate rinse: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies
    id
    BG001
    title
    Arm II (Supersaturated Calcium Phosphate Rinse)
  3. description
    Site not able to randomize.
    id
    BG002
    title
    Arm III (Enrolled Not Randomized)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.05
          value
          12.75
        2. group Id
          BG001
          spread
          4.54
          value
          13.02
        3. group Id
          BG002
          spread
          1.73
          value
          12.00
        4. group Id
          BG003
          spread
          4.79
          value
          12.88
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          104
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          122
        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
          value
          25
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          55
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          82
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          163
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          8
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          6
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          23
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          87
        2. group Id
          BG001
          value
          82
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          172
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          24
        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
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          9
      title
      Canada
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          105
        2. group Id
          BG001
          value
          102
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          210
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          6
      title
      Australia
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Puerto Rico
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      111
    2. group Id
      BG001
      value
      112
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      226
    units
    Participants
groups
  1. description
    Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. placebo: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies
    id
    BG000
    title
    Arm I (Placebo)
  2. description
    Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation. supersaturated calcium phosphate rinse: Mouth rinse questionnaire administration: Ancillary studies quality-of-life assessment: Ancillary studies
    id
    BG001
    title
    Arm II (Supersaturated Calcium Phosphate Rinse)
  3. description
    Site not able to randomize.
    id
    BG002
    title
    Arm III (Enrolled Not Randomized)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.05
          value
          12.75
        2. group Id
          BG001
          spread
          4.54
          value
          13.02
        3. group Id
          BG002
          spread
          1.73
          value
          12.00
        4. group Id
          BG003
          spread
          4.79
          value
          12.88
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          104
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          122
        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
          value
          25
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          55
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          82
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          163
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          8
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          6
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          23
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          87
        2. group Id
          BG001
          value
          82
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          172
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          24
        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
          5
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          9
      title
      Canada
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          105
        2. group Id
          BG001
          value
          102
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          210
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          6
      title
      Australia
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
      title
      Puerto Rico
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice