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NCT02953678 · BASELINE

Baseline characteristics

A Study of Ruxolitinib in Combination With Corticosteroids for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease (REACH-1) · Source last updated 2021-11-24

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
    units
    Participants
groups
  1. description
    Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
    id
    BG000
    title
    Ruxolitinib in Combination With Corticosteroids
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.18
          value
          52.9
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
    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
          58
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
      title
      < 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
      title
      ≥ 65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          35
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          60
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          66
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.64
          value
          170.2
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Height was not obtained for 5 participants.
    title
    Height
    unit Of Measure
    cm
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          21.651
          value
          78.64
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.193
          value
          26.83
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Height was not obtained for 5 participants; BMI could not be calculated for these participants.
    title
    Body Mass Index (BMI)
    unit Of Measure
    kg/m^2
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.301
          value
          1.91
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Height was not obtained for 5 participants; BSA could not be calculated for these participants.
    title
    Body Surface Area (BSA)
    unit Of Measure
    m^2
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
      title
      ECOG - 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          24
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
      title
      ECOG - 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          25
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
      title
      ECOG - 2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
      title
      ECOG - 3
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
      title
      ECOG - 4
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
      title
      ECOG - 5
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
      title
      Missing
    description
    ECOG scores are from 0-5: 0 = fully active, able to carry on all predisease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg, light house work, office work; 2 = ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3 = capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = completely disabled, cannot carry on any self-care, totally confined to bed or chair; and 5 = dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) grade at baseline
    unit Of Measure
    Participants
population Description
The efficacy evaluable population included all participants enrolled in the study.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      71
    units
    Participants
groups
  1. description
    Participants began oral administration of ruxolitinib at 5 mg BID; if stable after the first 3 days of treatment, the dose may be increased to 10 mg BID. Participants did receive prednisone 2.5 mg/kg per day orally (PO) or methylprednisolone 2.0 mg/kg per day IV.
    id
    BG000
    title
    Ruxolitinib in Combination With Corticosteroids
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          14.18
          value
          52.9
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
    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
          58
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
      title
      < 65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
      title
      ≥ 65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          35
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          60
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          66
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.64
          value
          170.2
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Height was not obtained for 5 participants.
    title
    Height
    unit Of Measure
    cm
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          21.651
          value
          78.64
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.193
          value
          26.83
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Height was not obtained for 5 participants; BMI could not be calculated for these participants.
    title
    Body Mass Index (BMI)
    unit Of Measure
    kg/m^2
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.301
          value
          1.91
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Height was not obtained for 5 participants; BSA could not be calculated for these participants.
    title
    Body Surface Area (BSA)
    unit Of Measure
    m^2
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
      title
      ECOG - 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          24
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
      title
      ECOG - 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          25
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
      title
      ECOG - 2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          17
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
      title
      ECOG - 3
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
      title
      ECOG - 4
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
      title
      ECOG - 5
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
      denoms
      1. counts
        1. group Id
          BG000
          value
          71
        units
        Participants
      title
      Missing
    description
    ECOG scores are from 0-5: 0 = fully active, able to carry on all predisease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, eg, light house work, office work; 2 = ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3 = capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = completely disabled, cannot carry on any self-care, totally confined to bed or chair; and 5 = dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) grade at baseline
    unit Of Measure
    Participants
population Description
The efficacy evaluable population included all participants enrolled in the study.

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

Preserved source evidence · Not medical advice