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NCT01550003 · BASELINE

Baseline characteristics

Pediatric Arthritis Study of Certolizumab Pegol · Source last updated 2024-10-23

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
      18
    2. group Id
      BG001
      value
      63
    3. group Id
      BG002
      value
      112
    4. group Id
      BG003
      value
      193
    units
    Participants
groups
  1. description
    Participants received CZP sc as a fixed dose based on their body weight Q2W or Q4W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
    id
    BG000
    title
    Any CZP Dose - Weight Group: 10 - <20 kg
  2. description
    Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
    id
    BG001
    title
    Any CZP Dose - Weight Group: 20 - <40 kg
  3. description
    Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
    id
    BG002
    title
    Any CZP Dose - Weight Group: >=40 kg
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.3
          value
          5.4
        2. group Id
          BG001
          spread
          2.0
          value
          9.1
        3. group Id
          BG002
          spread
          2.2
          value
          14.5
        4. group Id
          BG003
          spread
          3.8
          value
          11.9
    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
          18
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          86
        title
        24 months - <12 years
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          99
        4. group Id
          BG003
          value
          107
        title
        12 - <18 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          76
        4. group Id
          BG003
          value
          130
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          36
        4. group Id
          BG003
          value
          63
        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
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        title
        American Indian/ Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        title
        Black or African American
      4. 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
      5. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          85
        4. group Id
          BG003
          value
          155
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          22
        title
        Other/Mixed
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          55
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          85
        4. group Id
          BG003
          value
          138
        title
        Not Hispanic or Latino
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Baseline Characteristics refers to the Safety Set (SS) which consisted of all study participants in the Enrolled Set (ES) who have received at least 1 dose of study medication.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      18
    2. group Id
      BG001
      value
      63
    3. group Id
      BG002
      value
      112
    4. group Id
      BG003
      value
      193
    units
    Participants
groups
  1. description
    Participants received CZP sc as a fixed dose based on their body weight Q2W or Q4W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
    id
    BG000
    title
    Any CZP Dose - Weight Group: 10 - <20 kg
  2. description
    Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
    id
    BG001
    title
    Any CZP Dose - Weight Group: 20 - <40 kg
  3. description
    Participants received CZP sc as a fixed dose based on their body weight Q2W throughout the study. Participants started with 3 loading doses of CZP at Weeks 0, 2, and 4 followed by a maintenance dose for the duration of the study.
    id
    BG002
    title
    Any CZP Dose - Weight Group: >=40 kg
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          1.3
          value
          5.4
        2. group Id
          BG001
          spread
          2.0
          value
          9.1
        3. group Id
          BG002
          spread
          2.2
          value
          14.5
        4. group Id
          BG003
          spread
          3.8
          value
          11.9
    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
          18
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          86
        title
        24 months - <12 years
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          99
        4. group Id
          BG003
          value
          107
        title
        12 - <18 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          76
        4. group Id
          BG003
          value
          130
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          36
        4. group Id
          BG003
          value
          63
        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
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        title
        American Indian/ Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          5
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        title
        Black or African American
      4. 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
      5. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          85
        4. group Id
          BG003
          value
          155
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          22
        title
        Other/Mixed
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          55
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          85
        4. group Id
          BG003
          value
          138
        title
        Not Hispanic or Latino
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Baseline Characteristics refers to the Safety Set (SS) which consisted of all study participants in the Enrolled Set (ES) who have received at least 1 dose of study medication.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice