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NCT00092521 · BASELINE

Baseline characteristics

Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED) · Source last updated 2015-09-25

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
      2723
    2. group Id
      BG001
      value
      304
    3. group Id
      BG002
      value
      2732
    4. group Id
      BG003
      value
      5759
    units
    Participants
groups
  1. description
    The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
    id
    BG000
    title
    Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine
  2. description
    The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
    id
    BG001
    title
    Group 2 - Base Study Monovalent HPV (Type 16) Vaccine
  3. description
    The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
    id
    BG002
    title
    Group 3 - Base Study Placebo
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.8
          value
          20.2
        2. group Id
          BG001
          spread
          1.74
          value
          20.2
        3. group Id
          BG002
          spread
          1.8
          value
          20.3
        4. group Id
          BG003
          spread
          1.8
          value
          20.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          16
          upper Limit
          24
          value
          20
        2. group Id
          BG001
          lower Limit
          16
          upper Limit
          24
          value
          20
        3. group Id
          BG002
          lower Limit
          16
          upper Limit
          24
          value
          20
        4. group Id
          BG003
          lower Limit
          16
          upper Limit
          24
          value
          20
    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
          2723
        2. group Id
          BG001
          value
          304
        3. group Id
          BG002
          value
          2732
        4. group Id
          BG003
          value
          5759
      title
      16 to 24 Years of Age
    description
    Although the upper age limit for this study was 23 years old, four subjects aged 24 were randomized into the study.
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2723
        2. group Id
          BG001
          value
          304
        3. group Id
          BG002
          value
          2732
        4. group Id
          BG003
          value
          5759
        title
        Female
      2. 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
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          151
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          165
        4. group Id
          BG003
          value
          343
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          136
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          167
        4. group Id
          BG003
          value
          308
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          567
        2. group Id
          BG001
          value
          93
        3. group Id
          BG002
          value
          566
        4. group Id
          BG003
          value
          1226
      title
      Hispanic American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          22
      title
      Native American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1600
        2. group Id
          BG001
          value
          171
        3. group Id
          BG002
          value
          1558
        4. group Id
          BG003
          value
          3329
      title
      White
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          259
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          266
        4. group Id
          BG003
          value
          531
      title
      Other - Unspecified
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      2723
    2. group Id
      BG001
      value
      304
    3. group Id
      BG002
      value
      2732
    4. group Id
      BG003
      value
      5759
    units
    Participants
groups
  1. description
    The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
    id
    BG000
    title
    Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine
  2. description
    The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
    id
    BG001
    title
    Group 2 - Base Study Monovalent HPV (Type 16) Vaccine
  3. description
    The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo. The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study.
    id
    BG002
    title
    Group 3 - Base Study Placebo
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.8
          value
          20.2
        2. group Id
          BG001
          spread
          1.74
          value
          20.2
        3. group Id
          BG002
          spread
          1.8
          value
          20.3
        4. group Id
          BG003
          spread
          1.8
          value
          20.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          16
          upper Limit
          24
          value
          20
        2. group Id
          BG001
          lower Limit
          16
          upper Limit
          24
          value
          20
        3. group Id
          BG002
          lower Limit
          16
          upper Limit
          24
          value
          20
        4. group Id
          BG003
          lower Limit
          16
          upper Limit
          24
          value
          20
    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
          2723
        2. group Id
          BG001
          value
          304
        3. group Id
          BG002
          value
          2732
        4. group Id
          BG003
          value
          5759
      title
      16 to 24 Years of Age
    description
    Although the upper age limit for this study was 23 years old, four subjects aged 24 were randomized into the study.
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2723
        2. group Id
          BG001
          value
          304
        3. group Id
          BG002
          value
          2732
        4. group Id
          BG003
          value
          5759
        title
        Female
      2. 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
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          151
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          165
        4. group Id
          BG003
          value
          343
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          136
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          167
        4. group Id
          BG003
          value
          308
      title
      Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          567
        2. group Id
          BG001
          value
          93
        3. group Id
          BG002
          value
          566
        4. group Id
          BG003
          value
          1226
      title
      Hispanic American
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          22
      title
      Native American
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1600
        2. group Id
          BG001
          value
          171
        3. group Id
          BG002
          value
          1558
        4. group Id
          BG003
          value
          3329
      title
      White
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          259
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          266
        4. group Id
          BG003
          value
          531
      title
      Other - Unspecified
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice