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NCT02281084 · BASELINE

Baseline characteristics

Safety and Efficacy Study of CC-486 in Subjects With Myelodysplastic Syndromes · Source last updated 2024-10-04

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
      32
    2. group Id
      BG001
      value
      22
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      5
    5. group Id
      BG004
      value
      65
    units
    Participants
groups
  1. description
    Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
    id
    BG000
    title
    Stable Disease (SD) Cohort: Oral Azacitidine
  2. description
    Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
    id
    BG001
    title
    Progressive Disease (PD) Cohort: Oral Azacitidine
  3. description
    Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
    id
    BG002
    title
    Stable Disease Cohort: Oral Azacitidine and Durvalumab
  4. description
    Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
    id
    BG003
    title
    Progressive Disease Cohort: Oral Azacitidine and Durvalumab
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.62
          value
          73.9
        2. group Id
          BG001
          spread
          7.56
          value
          75.1
        3. group Id
          BG002
          spread
          7.21
          value
          70.0
        4. group Id
          BG003
          spread
          5.55
          value
          72.4
        5. group Id
          BG004
          spread
          7.42
          value
          73.9
    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
          12
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          19
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          46
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          57
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Black
      3. 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
          2
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      5. 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
        title
        American Indian or Alaska Native
      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
          2
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        title
        Not Collected or Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          60
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Refractory Anemia (RA) with Ringed Sideroblasts
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          14
        title
        Refractory Cytopenia with Multilineage Dysplasia
      3. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          19
        title
        RA With Excess Blasts-1 (RAEB-1)
      4. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          26
        title
        RA With Excess Blasts-2 (RAEB-2)
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
        title
        MDS Unclassified (MDS-U)
      6. 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
        title
        MDS Associated with Isolated del (5q)
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Missing
    description
    The World Health Organization (WHO) 2008 classification recognizes eight subtypes of MDS that are distinguished by the percentage of myeloblasts, presence or absence of ringed sideroblasts (i.e., erythroid precursors with iron deposits surrounding the nucleus), presence of a monocytosis or a deletion 5q.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Myelodysplastic Syndrome (MDS) World Health Organization Classification 2008
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          6
        title
        Low (0)
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          20
        title
        Intermediate 1 (0.5-1.0)
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          20
        title
        Intermediate (2) (1.0-2.0)
      4. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          18
        title
        High (2) (≥ 2.5)
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Unknown
    description
    The international prognostic scoring system (IPSS) is a standard for risk assessment in primary myelodysplastic syndromes (MDS) that categorizes prognoses taking into account cytogenetics, cytopenias, blasts and blood counts. The IPSS prognostic subgroups consist of low-, intermediate-1-, intermediate-2-, and high-risk groups. The scale is 0-3.5 at 0.5 increments. Scores of 0=Low; 0.5-1.0=Int-1; 1.5-2.0=Int-2; 2.5-3.5=High risk which corresponds to poorer prognosis.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Prognostic Scoring System Risk Classification
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          8
        title
        Refractory Anemia (RA)
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          8
        title
        Refractory Anemia with Ringed Sideroblasts (RARS)
      3. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          42
        title
        Refractory Anemia with Excess Blasts (RAEB)
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          6
        title
        RAEB in Transformation
      5. 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
        title
        Chronic Myelomonocytic Leukemia (CMML)
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Missing
    description
    FAB is a classification system for five (5) subtypes of myelodysplastic syndrome that are distinguished by the percentage of myeloblasts, presence or absence of ringed sideroblasts or a monocytosis.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    French-American-British (FAB) Classification
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          29.678
          value
          26.79
        2. group Id
          BG001
          spread
          33.835
          value
          26.97
        3. group Id
          BG002
          spread
          61.663
          value
          40.20
        4. group Id
          BG003
          spread
          30.524
          value
          23.51
        5. group Id
          BG004
          spread
          34.266
          value
          27.84
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time Since Initial Diagnosis of MDS
    unit Of Measure
    months
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          16
        title
        0 (Fully active)
      2. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          41
        title
        1 (Restricted but Ambulatory)
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          8
        title
        2 (Ambulatory But Unable to Work)
      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
        5. group Id
          BG004
          value
          0
        title
        3 (Limited Self-Care)
      5. 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
        title
        4 (Completely Disabled)
      6. 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
        title
        5 (Death)
    description
    ECOG performance status is used by doctors and researchers to assess how a subject's disease is progressing, assess how the disease affects the daily living activities of the subject and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          10
        title
        Dependent
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          48
        title
        Independent
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          7
        title
        Other
    description
    Baseline Platelet transfusion dependence is defined as ≥ 2 transfusions (in units) during the 56 days prior to treatment. Platelet transfusion independence is defined as 0 transfusions (in units) during the 56 days prior to treatment.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Baseline Platelet Transfusion Status
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          17
        title
        Dependent
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          19
        title
        Independent
      3. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          29
        title
        Other
    description
    Baseline RBC Transfusion Dependence is defined as ≥ 4 transfusions (in units) during the 56 days prior to treatment. RBC transfusion independence is defined as 0 transfusions (in units) during the 56 days prior to treatment.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Baseline Red Blood Cell (RBC) Transfusion Status
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.00
          upper Limit
          10.0
          value
          4.00
        2. group Id
          BG001
          lower Limit
          0.0
          upper Limit
          7.0
          value
          3.50
        3. group Id
          BG002
          lower Limit
          0.0
          upper Limit
          7.0
          value
          3.00
        4. group Id
          BG003
          lower Limit
          0.0
          upper Limit
          15.0
          value
          4.00
        5. group Id
          BG004
          lower Limit
          0.0
          upper Limit
          15.0
          value
          4.00
    description
    Documentation of all red blood cell transfusions received by the participant within 8 weeks (56 days) prior to the first dose of study drug.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Average Red Blood Cell (RBC) Transfusion Requirement
    unit Of Measure
    units per 56 days
population Description
The intent-to-treat population included all enrolled participants who received at least one dose of investigational product (IP)..
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      32
    2. group Id
      BG001
      value
      22
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      5
    5. group Id
      BG004
      value
      65
    units
    Participants
groups
  1. description
    Participants were given oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
    id
    BG000
    title
    Stable Disease (SD) Cohort: Oral Azacitidine
  2. description
    Participants were given oral azacitidine 100 mg, 150mg, or 200mg tablets BID on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
    id
    BG001
    title
    Progressive Disease (PD) Cohort: Oral Azacitidine
  3. description
    Participants received 100 mg oral azacitidine (AZA) tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab (Durva) 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
    id
    BG002
    title
    Stable Disease Cohort: Oral Azacitidine and Durvalumab
  4. description
    Participants received 100 mg oral azacitidine tablets BID on days 1 to 14 or days 1 to 21 of each 28-day treatment cycle and durvalumab 1500 mg by intravenous infusion on day 1 of each 28-day treatment cycle; participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
    id
    BG003
    title
    Progressive Disease Cohort: Oral Azacitidine and Durvalumab
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.62
          value
          73.9
        2. group Id
          BG001
          spread
          7.56
          value
          75.1
        3. group Id
          BG002
          spread
          7.21
          value
          70.0
        4. group Id
          BG003
          spread
          5.55
          value
          72.4
        5. group Id
          BG004
          spread
          7.42
          value
          73.9
    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
          12
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          19
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          46
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          57
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Black
      3. 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
          2
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      5. 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
        title
        American Indian or Alaska Native
      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
          2
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        title
        Not Collected or Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          60
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Refractory Anemia (RA) with Ringed Sideroblasts
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          14
        title
        Refractory Cytopenia with Multilineage Dysplasia
      3. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          19
        title
        RA With Excess Blasts-1 (RAEB-1)
      4. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          26
        title
        RA With Excess Blasts-2 (RAEB-2)
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
        title
        MDS Unclassified (MDS-U)
      6. 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
        title
        MDS Associated with Isolated del (5q)
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Missing
    description
    The World Health Organization (WHO) 2008 classification recognizes eight subtypes of MDS that are distinguished by the percentage of myeloblasts, presence or absence of ringed sideroblasts (i.e., erythroid precursors with iron deposits surrounding the nucleus), presence of a monocytosis or a deletion 5q.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Myelodysplastic Syndrome (MDS) World Health Organization Classification 2008
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          6
        title
        Low (0)
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          20
        title
        Intermediate 1 (0.5-1.0)
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          20
        title
        Intermediate (2) (1.0-2.0)
      4. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          18
        title
        High (2) (≥ 2.5)
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Unknown
    description
    The international prognostic scoring system (IPSS) is a standard for risk assessment in primary myelodysplastic syndromes (MDS) that categorizes prognoses taking into account cytogenetics, cytopenias, blasts and blood counts. The IPSS prognostic subgroups consist of low-, intermediate-1-, intermediate-2-, and high-risk groups. The scale is 0-3.5 at 0.5 increments. Scores of 0=Low; 0.5-1.0=Int-1; 1.5-2.0=Int-2; 2.5-3.5=High risk which corresponds to poorer prognosis.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Prognostic Scoring System Risk Classification
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          8
        title
        Refractory Anemia (RA)
      2. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          8
        title
        Refractory Anemia with Ringed Sideroblasts (RARS)
      3. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          42
        title
        Refractory Anemia with Excess Blasts (RAEB)
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          6
        title
        RAEB in Transformation
      5. 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
        title
        Chronic Myelomonocytic Leukemia (CMML)
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        title
        Missing
    description
    FAB is a classification system for five (5) subtypes of myelodysplastic syndrome that are distinguished by the percentage of myeloblasts, presence or absence of ringed sideroblasts or a monocytosis.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    French-American-British (FAB) Classification
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          29.678
          value
          26.79
        2. group Id
          BG001
          spread
          33.835
          value
          26.97
        3. group Id
          BG002
          spread
          61.663
          value
          40.20
        4. group Id
          BG003
          spread
          30.524
          value
          23.51
        5. group Id
          BG004
          spread
          34.266
          value
          27.84
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Time Since Initial Diagnosis of MDS
    unit Of Measure
    months
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          16
        title
        0 (Fully active)
      2. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          41
        title
        1 (Restricted but Ambulatory)
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          8
        title
        2 (Ambulatory But Unable to Work)
      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
        5. group Id
          BG004
          value
          0
        title
        3 (Limited Self-Care)
      5. 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
        title
        4 (Completely Disabled)
      6. 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
        title
        5 (Death)
    description
    ECOG performance status is used by doctors and researchers to assess how a subject's disease is progressing, assess how the disease affects the daily living activities of the subject and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          10
        title
        Dependent
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          48
        title
        Independent
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          7
        title
        Other
    description
    Baseline Platelet transfusion dependence is defined as ≥ 2 transfusions (in units) during the 56 days prior to treatment. Platelet transfusion independence is defined as 0 transfusions (in units) during the 56 days prior to treatment.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Baseline Platelet Transfusion Status
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          17
        title
        Dependent
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          19
        title
        Independent
      3. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          29
        title
        Other
    description
    Baseline RBC Transfusion Dependence is defined as ≥ 4 transfusions (in units) during the 56 days prior to treatment. RBC transfusion independence is defined as 0 transfusions (in units) during the 56 days prior to treatment.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Baseline Red Blood Cell (RBC) Transfusion Status
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.00
          upper Limit
          10.0
          value
          4.00
        2. group Id
          BG001
          lower Limit
          0.0
          upper Limit
          7.0
          value
          3.50
        3. group Id
          BG002
          lower Limit
          0.0
          upper Limit
          7.0
          value
          3.00
        4. group Id
          BG003
          lower Limit
          0.0
          upper Limit
          15.0
          value
          4.00
        5. group Id
          BG004
          lower Limit
          0.0
          upper Limit
          15.0
          value
          4.00
    description
    Documentation of all red blood cell transfusions received by the participant within 8 weeks (56 days) prior to the first dose of study drug.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Average Red Blood Cell (RBC) Transfusion Requirement
    unit Of Measure
    units per 56 days
population Description
The intent-to-treat population included all enrolled participants who received at least one dose of investigational product (IP)..

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