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NCT01736683 · BASELINE

Baseline characteristics

Study of Sotatercept for the Treatment of Anemia in low-or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) or Non-proliferative Chronic Myelomonocytic Leukemia (CMML) · Source last updated 2022-10-24

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
      7
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      21
    4. group Id
      BG003
      value
      35
    5. group Id
      BG004
      value
      5
    6. group Id
      BG005
      value
      74
    units
    Participants
groups
  1. description
    Sotatercept 0.1 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to either the 0.1 mg/kg arm or the 0.3 mg/kg arm. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/5 subjects in Cycle 1 in the 0.1 mg/kg and 0.3 mg/kg treatment groups, the 0.5 mg/kg treatment group began inclusion in the randomization scheme.
    id
    BG000
    title
    Sotatercept 0.1 mg/kg
  2. description
    Sotatercept 0.3 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to either the 0.1 mg/kg arm or the 0.3 mg/kg arm. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/5 subjects in Cycle 1 in the 0.1 mg/kg and 0.3 mg/kg treatment groups, the 0.5 mg/kg treatment group began inclusion in the randomization scheme.
    id
    BG001
    title
    Sotatercept 0.3 mg/kg
  3. description
    Sotatercept 0.5 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/6 subjects in Cycle 1 in the 0.5 mg/kg treatment group, the 1.0 mg/kg treatment group began inclusion in the randomization scheme.
    id
    BG002
    title
    Sotatercept 0.5 mg/kg
  4. description
    Sotatercept 1.0 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/6 subjects in Cycle 1 in the 1.0 mg/kg treatment group, the 2.0 mg/kg treatment group began inclusion in the randomization scheme. Following evaluation of all treatment group data by the Steering Committee, enrollment continued only in the 1.0 mg/kg arm because the arm had the greatest frequency of erythroid hematological improvement (HI-E).
    id
    BG003
    title
    Sotatercept 1.0 mg/kg
  5. description
    Sotatercept 2.0 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. The 2.0 mg/kg sotatercept dose was reduced to 1.5 mg/kg for ongoing and newly enrolled participants by protocol amendment.
    id
    BG004
    title
    Sotatercept 2.0 mg/kg
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.3
          value
          67
        2. group Id
          BG001
          spread
          6.9
          value
          75
        3. group Id
          BG002
          spread
          8.0
          value
          69
        4. group Id
          BG003
          spread
          8.2
          value
          71
        5. group Id
          BG004
          spread
          13.0
          value
          69
        6. group Id
          BG005
          spread
          8.4
          value
          70
    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
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          17
        title
        <65 years
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          32
        title
        >=65 - <75 years
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          25
        title
        >=75 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          28
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          46
        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
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          49
        title
        Not Hispanic or Latino
      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
          16
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          23
        title
        Unknown or Not Reported
    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
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        American Indian or Alaska Native
      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
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        title
        Asian
      3. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      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
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          48
        title
        White
      6. measurements
        1. comment
          not asked on CRF
          group Id
          BG000
          value
          NA
        2. comment
          not asked on CRF
          group Id
          BG001
          value
          NA
        3. comment
          not asked on CRF
          group Id
          BG002
          value
          NA
        4. comment
          not asked on CRF
          group Id
          BG003
          value
          NA
        5. comment
          not asked on CRF
          group Id
          BG004
          value
          NA
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          24
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          50
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          24
      title
      France
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.110
          value
          1.70
        2. group Id
          BG001
          spread
          0.054
          value
          1.75
        3. group Id
          BG002
          spread
          0.093
          value
          1.70
        4. group Id
          BG003
          spread
          0.089
          value
          1.68
        5. group Id
          BG004
          spread
          0.043
          value
          1.56
        6. group Id
          BG005
          spread
          0.095
          value
          1.68
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    meters
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          21.79
          value
          85.3
        2. group Id
          BG001
          spread
          13.90
          value
          79.5
        3. group Id
          BG002
          spread
          13.97
          value
          77.9
        4. group Id
          BG003
          spread
          15.55
          value
          73.5
        5. group Id
          BG004
          spread
          7.25
          value
          56.4
        6. group Id
          BG005
          spread
          16.14
          value
          75.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          29
        title
        <=200 mIU/mL
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          15
        title
        >200 to <=500 mIU/mL
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          25
        title
        >500 mIU/mL
      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
          4
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          5
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Erythropoietin level
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          12
        title
        < 4 units (Low Transfusion Burden)
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          27
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          62
        title
        >= 4 units (High Transfusion Burden)
    description
    RBC units transfused during 56 days prior to the start of treatment.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Red Blood Cell (RBC) Transfusion Burden Categories
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        title
        0 ESA therapies
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          23
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          45
        title
        1 ESA therapy
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          24
        title
        2 ESA therapies
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        title
        3 ESA therapies
    description
    Myelodysplastic Syndromes (MDS)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Previous Erythropoiesis-Stimulating Agents (ESA) Therapies for Myelodysplastic Syndromes
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          11
        title
        0 non-ESA agents
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          25
        title
        1 non-ESA agent
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          17
        title
        2 non-ESA agents
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          8
        title
        3 non-ESA agents
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          6
        title
        4 non-ESA agents
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        title
        5 non-ESA agents
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          5
        title
        >5 non-ESA agents
    description
    Erythropoiesis-Stimulating Agents (ESA)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Previous Non-ESA Agents for Myelodysplastic Syndromes (MDS)
    unit Of Measure
    Participants
population Description
All randomized participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      7
    2. group Id
      BG001
      value
      6
    3. group Id
      BG002
      value
      21
    4. group Id
      BG003
      value
      35
    5. group Id
      BG004
      value
      5
    6. group Id
      BG005
      value
      74
    units
    Participants
groups
  1. description
    Sotatercept 0.1 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to either the 0.1 mg/kg arm or the 0.3 mg/kg arm. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/5 subjects in Cycle 1 in the 0.1 mg/kg and 0.3 mg/kg treatment groups, the 0.5 mg/kg treatment group began inclusion in the randomization scheme.
    id
    BG000
    title
    Sotatercept 0.1 mg/kg
  2. description
    Sotatercept 0.3 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to either the 0.1 mg/kg arm or the 0.3 mg/kg arm. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/5 subjects in Cycle 1 in the 0.1 mg/kg and 0.3 mg/kg treatment groups, the 0.5 mg/kg treatment group began inclusion in the randomization scheme.
    id
    BG001
    title
    Sotatercept 0.3 mg/kg
  3. description
    Sotatercept 0.5 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/6 subjects in Cycle 1 in the 0.5 mg/kg treatment group, the 1.0 mg/kg treatment group began inclusion in the randomization scheme.
    id
    BG002
    title
    Sotatercept 0.5 mg/kg
  4. description
    Sotatercept 1.0 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. Based upon the occurrence of dose-limiting toxicity (DLT) in ≤ 1/6 subjects in Cycle 1 in the 1.0 mg/kg treatment group, the 2.0 mg/kg treatment group began inclusion in the randomization scheme. Following evaluation of all treatment group data by the Steering Committee, enrollment continued only in the 1.0 mg/kg arm because the arm had the greatest frequency of erythroid hematological improvement (HI-E).
    id
    BG003
    title
    Sotatercept 1.0 mg/kg
  5. description
    Sotatercept 2.0 mg/kg administered via subcutaneous injection every third week (Q3W). Participants were randomized to one of the active treatment arms. Efficacy and safety data were assessed by a Steering Committee. The 2.0 mg/kg sotatercept dose was reduced to 1.5 mg/kg for ongoing and newly enrolled participants by protocol amendment.
    id
    BG004
    title
    Sotatercept 2.0 mg/kg
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.3
          value
          67
        2. group Id
          BG001
          spread
          6.9
          value
          75
        3. group Id
          BG002
          spread
          8.0
          value
          69
        4. group Id
          BG003
          spread
          8.2
          value
          71
        5. group Id
          BG004
          spread
          13.0
          value
          69
        6. group Id
          BG005
          spread
          8.4
          value
          70
    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
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          17
        title
        <65 years
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          32
        title
        >=65 - <75 years
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          25
        title
        >=75 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          28
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          46
        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
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          19
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          49
        title
        Not Hispanic or Latino
      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
          16
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          23
        title
        Unknown or Not Reported
    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
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        American Indian or Alaska Native
      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
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        title
        Asian
      3. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      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
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          48
        title
        White
      6. measurements
        1. comment
          not asked on CRF
          group Id
          BG000
          value
          NA
        2. comment
          not asked on CRF
          group Id
          BG001
          value
          NA
        3. comment
          not asked on CRF
          group Id
          BG002
          value
          NA
        4. comment
          not asked on CRF
          group Id
          BG003
          value
          NA
        5. comment
          not asked on CRF
          group Id
          BG004
          value
          NA
        6. comment
          Total not calculated because data are not available (NA) in one or more arms.
          group Id
          BG005
          value
          NA
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          24
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          18
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          50
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          24
      title
      France
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.110
          value
          1.70
        2. group Id
          BG001
          spread
          0.054
          value
          1.75
        3. group Id
          BG002
          spread
          0.093
          value
          1.70
        4. group Id
          BG003
          spread
          0.089
          value
          1.68
        5. group Id
          BG004
          spread
          0.043
          value
          1.56
        6. group Id
          BG005
          spread
          0.095
          value
          1.68
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    meters
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          21.79
          value
          85.3
        2. group Id
          BG001
          spread
          13.90
          value
          79.5
        3. group Id
          BG002
          spread
          13.97
          value
          77.9
        4. group Id
          BG003
          spread
          15.55
          value
          73.5
        5. group Id
          BG004
          spread
          7.25
          value
          56.4
        6. group Id
          BG005
          spread
          16.14
          value
          75.2
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          29
        title
        <=200 mIU/mL
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          15
        title
        >200 to <=500 mIU/mL
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          25
        title
        >500 mIU/mL
      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
          4
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          5
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Erythropoietin level
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          12
        title
        < 4 units (Low Transfusion Burden)
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          27
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          62
        title
        >= 4 units (High Transfusion Burden)
    description
    RBC units transfused during 56 days prior to the start of treatment.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Red Blood Cell (RBC) Transfusion Burden Categories
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        title
        0 ESA therapies
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          23
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          45
        title
        1 ESA therapy
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          24
        title
        2 ESA therapies
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        title
        3 ESA therapies
    description
    Myelodysplastic Syndromes (MDS)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Previous Erythropoiesis-Stimulating Agents (ESA) Therapies for Myelodysplastic Syndromes
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          11
        title
        0 non-ESA agents
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          25
        title
        1 non-ESA agent
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          17
        title
        2 non-ESA agents
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          8
        title
        3 non-ESA agents
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          6
        title
        4 non-ESA agents
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        title
        5 non-ESA agents
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          5
        title
        >5 non-ESA agents
    description
    Erythropoiesis-Stimulating Agents (ESA)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Number of Previous Non-ESA Agents for Myelodysplastic Syndromes (MDS)
    unit Of Measure
    Participants
population Description
All randomized participants

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Preserved source evidence · Not medical advice