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NCT03051516 · BASELINE

Baseline characteristics

HPV Vaccine Therapy in Interrupting Progression in Patients With High-Grade Vulvar or Anal Lesions · Source last updated 2024-02-28

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
      91
    2. group Id
      BG001
      value
      94
    3. group Id
      BG002
      value
      185
    units
    Participants
groups
  1. description
    Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM
    id
    BG000
    title
    Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)
  2. description
    Patients receive placebo IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Placebo Administration: Given IM Questionnaire Administration: Ancillary studies
    id
    BG001
    title
    Arm II (Placebo)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          47
          upper Limit
          61
          value
          53
        2. group Id
          BG001
          lower Limit
          51
          upper Limit
          63
          value
          57
        3. group Id
          BG002
          lower Limit
          48
          upper Limit
          62
          value
          55
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          99
      title
      Women
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          85
      title
      Men
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Transgender women
    param Type
    NUMBER
    title
    Sex/Gender, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          89
        3. group Id
          BG002
          value
          173
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        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
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          15
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          145
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          12
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        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
          91
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          185
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          103
        title
        Anal
      2. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          82
        title
        Vulvar
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Anatomic Site of HSIL (high-grade squamous intraepithelial lesion)
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          92
        title
        Never
      2. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          55
        title
        Former
      3. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          38
        title
        Current
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Smoking Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          71
        title
        HIV Positive
      2. measurements
        1. group Id
          BG000
          value
          59
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          114
        title
        HIV Negative
    param Type
    COUNT_OF_PARTICIPANTS
    title
    HIV Status
    unit Of Measure
    Participants
population Description
Participants who have completed Enrollment Visit and had at least 30 days follow-up after the initial dose of vaccine (n=185) were included in the intention-to-treat analysis and are considered part of the Baseline Analysis Population. Three participants (2 in Arm I/vaccine and 1 in Arm II/placebo) were excluded from analysis due to completing only one vaccination before study exit.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      91
    2. group Id
      BG001
      value
      94
    3. group Id
      BG002
      value
      185
    units
    Participants
groups
  1. description
    Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Recombinant Human Papillomavirus Nonavalent Vaccine: Given IM
    id
    BG000
    title
    Arm I (Recombinant Human Papillomavirus Nonavalent Vaccine)
  2. description
    Patients receive placebo IM at baseline, 2 months, and 6 months. Laboratory Biomarker Analysis: Correlative studies Placebo Administration: Given IM Questionnaire Administration: Ancillary studies
    id
    BG001
    title
    Arm II (Placebo)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          47
          upper Limit
          61
          value
          53
        2. group Id
          BG001
          lower Limit
          51
          upper Limit
          63
          value
          57
        3. group Id
          BG002
          lower Limit
          48
          upper Limit
          62
          value
          55
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          99
      title
      Women
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          85
      title
      Men
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Transgender women
    param Type
    NUMBER
    title
    Sex/Gender, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          89
        3. group Id
          BG002
          value
          173
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        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
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          15
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          145
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          12
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        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
          91
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          185
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          103
        title
        Anal
      2. measurements
        1. group Id
          BG000
          value
          41
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          82
        title
        Vulvar
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Anatomic Site of HSIL (high-grade squamous intraepithelial lesion)
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          92
        title
        Never
      2. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          55
        title
        Former
      3. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          38
        title
        Current
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Smoking Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          32
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          71
        title
        HIV Positive
      2. measurements
        1. group Id
          BG000
          value
          59
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          114
        title
        HIV Negative
    param Type
    COUNT_OF_PARTICIPANTS
    title
    HIV Status
    unit Of Measure
    Participants
population Description
Participants who have completed Enrollment Visit and had at least 30 days follow-up after the initial dose of vaccine (n=185) were included in the intention-to-treat analysis and are considered part of the Baseline Analysis Population. Three participants (2 in Arm I/vaccine and 1 in Arm II/placebo) were excluded from analysis due to completing only one vaccination before study exit.

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Preserved source evidence · Not medical advice