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NCT04924608 · BASELINE

Baseline characteristics

Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas · Source last updated 2026-03-23

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
      71
    2. group Id
      BG001
      value
      74
    3. group Id
      BG002
      value
      145
    units
    Participants
groups
  1. description
    Actual Treatment Group
    id
    BG000
    title
    Selumetinib 25 mg/m2
  2. description
    Actual Treatment Group
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.42
          value
          32.6
        2. group Id
          BG001
          spread
          8.72
          value
          29.8
        3. group Id
          BG002
          spread
          10.19
          value
          31.2
    description
    Baseline characteristics were collected at screening period
    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
          38
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          70
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          75
        title
        Male
    description
    Baseline characteristics were collected at screening period
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          14
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          126
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        Unknown or Not Reported
    description
    Baseline characteristic were collected at screening period
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          103
      title
      Baseline PAINS-pNF chronic target PN pain intensity score >= 3
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          42
      title
      Baseline PAINS-pNF chronic target PN pain intensity score < 3
    description
    The PAINS-pNF (Pain Intensity Scale for Plexiform Neurofibroma) chronic target PN pain intensity measures the participants' experience of chronic PN-related pain intensity with score from 0 (no chronic tumor pain) to 10 (worst chronic tumor pain). Baseline characteristics were collected at screening period.
    param Type
    NUMBER
    title
    Baseline PAINS-pNF chronic target PN pain intensity score
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.3702
          value
          163.517
        2. group Id
          BG001
          spread
          12.2517
          value
          165.798
        3. group Id
          BG002
          spread
          10.9784
          value
          164.698
    description
    Baseline characteristics were collected at screening period
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    cm
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          15.9763
          value
          65.896
        2. group Id
          BG001
          spread
          17.3971
          value
          66.271
        3. group Id
          BG002
          spread
          16.6596
          value
          66.087
    description
    Baseline characteristics were collected at screening period
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.2319
          value
          1.713
        2. group Id
          BG001
          spread
          0.2620
          value
          1.732
        3. group Id
          BG002
          spread
          0.2471
          value
          1.722
    description
    Baseline Body Surface Area. Baseline characteristics were collected at screening period
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    BSA
    unit Of Measure
    m^2
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          24
      title
      China
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          61
      title
      Europe (includes France, Germany, Italy, Poland, Russia, Spain, and United Kingdom)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          15
      title
      Japan
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          45
      title
      Rest of World (includes Australia, Brazil, Canada, and United States)
    description
    Baseline characteristics were collected at screening period
    param Type
    NUMBER
    title
    Geographical region
    unit Of Measure
    count
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          45
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          81
      title
      White
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
      title
      Other
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      Not Reported
    description
    Baseline characteristics were collected at screening period
    param Type
    NUMBER
    title
    Race
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      71
    2. group Id
      BG001
      value
      74
    3. group Id
      BG002
      value
      145
    units
    Participants
groups
  1. description
    Actual Treatment Group
    id
    BG000
    title
    Selumetinib 25 mg/m2
  2. description
    Actual Treatment Group
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.42
          value
          32.6
        2. group Id
          BG001
          spread
          8.72
          value
          29.8
        3. group Id
          BG002
          spread
          10.19
          value
          31.2
    description
    Baseline characteristics were collected at screening period
    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
          38
        2. group Id
          BG001
          value
          32
        3. group Id
          BG002
          value
          70
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          33
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          75
        title
        Male
    description
    Baseline characteristics were collected at screening period
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          14
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          63
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          126
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        Unknown or Not Reported
    description
    Baseline characteristic were collected at screening period
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          103
      title
      Baseline PAINS-pNF chronic target PN pain intensity score >= 3
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          42
      title
      Baseline PAINS-pNF chronic target PN pain intensity score < 3
    description
    The PAINS-pNF (Pain Intensity Scale for Plexiform Neurofibroma) chronic target PN pain intensity measures the participants' experience of chronic PN-related pain intensity with score from 0 (no chronic tumor pain) to 10 (worst chronic tumor pain). Baseline characteristics were collected at screening period.
    param Type
    NUMBER
    title
    Baseline PAINS-pNF chronic target PN pain intensity score
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.3702
          value
          163.517
        2. group Id
          BG001
          spread
          12.2517
          value
          165.798
        3. group Id
          BG002
          spread
          10.9784
          value
          164.698
    description
    Baseline characteristics were collected at screening period
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    cm
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          15.9763
          value
          65.896
        2. group Id
          BG001
          spread
          17.3971
          value
          66.271
        3. group Id
          BG002
          spread
          16.6596
          value
          66.087
    description
    Baseline characteristics were collected at screening period
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.2319
          value
          1.713
        2. group Id
          BG001
          spread
          0.2620
          value
          1.732
        3. group Id
          BG002
          spread
          0.2471
          value
          1.722
    description
    Baseline Body Surface Area. Baseline characteristics were collected at screening period
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    BSA
    unit Of Measure
    m^2
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          24
      title
      China
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          61
      title
      Europe (includes France, Germany, Italy, Poland, Russia, Spain, and United Kingdom)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          15
      title
      Japan
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          45
      title
      Rest of World (includes Australia, Brazil, Canada, and United States)
    description
    Baseline characteristics were collected at screening period
    param Type
    NUMBER
    title
    Geographical region
    unit Of Measure
    count
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          45
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          9
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          81
      title
      White
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
      title
      Other
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      Not Reported
    description
    Baseline characteristics were collected at screening period
    param Type
    NUMBER
    title
    Race
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice