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NCT01772420 · BASELINE

Baseline characteristics

Phase II Study of Lenalidomide and Eltrombopag in Patients With Symptomatic Anemia · Source last updated 2023-07-27

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
      16
    2. group Id
      BG001
      value
      15
    3. group Id
      BG002
      value
      21
    4. group Id
      BG003
      value
      52
    units
    Participants
groups
  1. description
    Patients with baseline platelet counts \>50,000 k/uL received lenalidomide (LEN) PO daily or QOD on days 1-21. If platelet counts fell below 50,000 k/uL during treatment, patients discontinued LEN and received eltrombopag olamine (ELT) PO daily or QOD until platelet counts \> 50,000 k/uL were achieved, and then maintained for 2 weeks thereafter. If a platelet count \>50,000 k/uL was maintained, patients discontinued ELT and resumed only LEN as a single agent (PO daily or QOD). If platelets fell below 50,000 k/uL a second time, LEN was stopped and ELT was re-initiated at the dose last given to the patient. Once platelet counts were \>50,000 k/uL and maintained for 2 weeks, patients resumed LEN concurrently with ELT for all subsequent courses. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO
    id
    BG000
    title
    Arm A (Platelets > 50,000 k/uL) LEN Initiation
  2. description
    Patients with baseline platelet counts \<50,000 k/uL received eltrombopag olamine (ELT) PO daily or QOD on days 1-28 until a platelet count \>50,000 k/uL was achieved. Once a platelet count\>50,000 k/uL was achieved the ELT dose was maintained for two weeks. After two weeks ELT was discontinued and LEN was started as in Arm A (i.e., eltrombopag olamine discontinued and lenalidomide started). Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was \>10.0 g/dL and didn't decrease while on study drug. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO
    id
    BG001
    title
    Arm B (Platelets < 50,000 k/uL) ELT Initiation With Potential LEN Combination
  3. description
    Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was \>10.0 g/dL and didn't decrease while on study drug. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies
    id
    BG002
    title
    Arm C (Platelets < 50,000 k/uL) ELT Monotherapy
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          59
          upper Limit
          86
          value
          74
        2. group Id
          BG001
          lower Limit
          56
          upper Limit
          85
          value
          73
        3. group Id
          BG002
          lower Limit
          34
          upper Limit
          93
          value
          68
        4. group Id
          BG003
          lower Limit
          34
          upper Limit
          93
          value
          71
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          15
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          37
        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
          11
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          29
      title
      Non-Hispanic White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          9
      title
      Non-Hispanic Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          11
      title
      Hispanic
    4. 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
          2
      title
      Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Unknown (Not Documented)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          52
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          6.2
          upper Limit
          9.5
          value
          8.2
        2. group Id
          BG001
          lower Limit
          6.4
          upper Limit
          10.8
          value
          8.1
        3. group Id
          BG002
          lower Limit
          6.1
          upper Limit
          11.7
          value
          8.6
        4. group Id
          BG003
          lower Limit
          6.1
          upper Limit
          11.7
          value
          8.4
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Baseline Hemoglobin
    unit Of Measure
    g/dL
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          88
          upper Limit
          457
          value
          257
        2. group Id
          BG001
          lower Limit
          16
          upper Limit
          280
          value
          134
        3. group Id
          BG002
          lower Limit
          1
          upper Limit
          97
          value
          19
        4. group Id
          BG003
          lower Limit
          1
          upper Limit
          457
          value
          126
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Baseline Platelet
    unit Of Measure
    platelets x10^9/L
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          5
          value
          1.96
        2. group Id
          BG001
          lower Limit
          0
          upper Limit
          6
          value
          1.87
        3. group Id
          BG002
          lower Limit
          0
          upper Limit
          8
          value
          1.8
        4. group Id
          BG003
          lower Limit
          0
          upper Limit
          8
          value
          1.87
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Blast Count
    unit Of Measure
    percentage of blasts in bone marrow cell
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          49
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Myelodysplastic Syndrome (MDS)
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. 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
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Chronic Myelomonocytic Leukemia (CMML)
    unit Of Measure
    Participants
  10. 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
          1
        title
        Very Low Risk
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          24
        title
        Low Risk
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          27
        title
        Intermediate Risk
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Revised International Prognostic Scoring System (IPSS-R) for Myelodysplastic Syndrome (MDS)
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          3
          value
          0.63
        2. group Id
          BG001
          lower Limit
          0
          upper Limit
          2
          value
          0.53
        3. group Id
          BG002
          lower Limit
          0
          upper Limit
          3
          value
          0.48
        4. group Id
          BG003
          lower Limit
          0
          upper Limit
          3
          value
          0.54
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Number of Prior Treatments
    unit Of Measure
    Prior Treatments
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      16
    2. group Id
      BG001
      value
      15
    3. group Id
      BG002
      value
      21
    4. group Id
      BG003
      value
      52
    units
    Participants
groups
  1. description
    Patients with baseline platelet counts \>50,000 k/uL received lenalidomide (LEN) PO daily or QOD on days 1-21. If platelet counts fell below 50,000 k/uL during treatment, patients discontinued LEN and received eltrombopag olamine (ELT) PO daily or QOD until platelet counts \> 50,000 k/uL were achieved, and then maintained for 2 weeks thereafter. If a platelet count \>50,000 k/uL was maintained, patients discontinued ELT and resumed only LEN as a single agent (PO daily or QOD). If platelets fell below 50,000 k/uL a second time, LEN was stopped and ELT was re-initiated at the dose last given to the patient. Once platelet counts were \>50,000 k/uL and maintained for 2 weeks, patients resumed LEN concurrently with ELT for all subsequent courses. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO
    id
    BG000
    title
    Arm A (Platelets > 50,000 k/uL) LEN Initiation
  2. description
    Patients with baseline platelet counts \<50,000 k/uL received eltrombopag olamine (ELT) PO daily or QOD on days 1-28 until a platelet count \>50,000 k/uL was achieved. Once a platelet count\>50,000 k/uL was achieved the ELT dose was maintained for two weeks. After two weeks ELT was discontinued and LEN was started as in Arm A (i.e., eltrombopag olamine discontinued and lenalidomide started). Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was \>10.0 g/dL and didn't decrease while on study drug. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies Lenalidomide: Given PO
    id
    BG001
    title
    Arm B (Platelets < 50,000 k/uL) ELT Initiation With Potential LEN Combination
  3. description
    Patients in Arm B were permitted to stay on ELT alone if a hematologic response on ELT was achieved as defined by the 2006 International Working Group (IWG) consensus criteria, or if baseline hemoglobin was \>10.0 g/dL and didn't decrease while on study drug. Treatment repeated every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Eltrombopag Olamine: Given PO Laboratory Biomarker Analysis: Correlative studies
    id
    BG002
    title
    Arm C (Platelets < 50,000 k/uL) ELT Monotherapy
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          59
          upper Limit
          86
          value
          74
        2. group Id
          BG001
          lower Limit
          56
          upper Limit
          85
          value
          73
        3. group Id
          BG002
          lower Limit
          34
          upper Limit
          93
          value
          68
        4. group Id
          BG003
          lower Limit
          34
          upper Limit
          93
          value
          71
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          15
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          37
        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
          11
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          29
      title
      Non-Hispanic White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          9
      title
      Non-Hispanic Black
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          11
      title
      Hispanic
    4. 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
          2
      title
      Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
      title
      Unknown (Not Documented)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          52
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          6.2
          upper Limit
          9.5
          value
          8.2
        2. group Id
          BG001
          lower Limit
          6.4
          upper Limit
          10.8
          value
          8.1
        3. group Id
          BG002
          lower Limit
          6.1
          upper Limit
          11.7
          value
          8.6
        4. group Id
          BG003
          lower Limit
          6.1
          upper Limit
          11.7
          value
          8.4
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Baseline Hemoglobin
    unit Of Measure
    g/dL
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          88
          upper Limit
          457
          value
          257
        2. group Id
          BG001
          lower Limit
          16
          upper Limit
          280
          value
          134
        3. group Id
          BG002
          lower Limit
          1
          upper Limit
          97
          value
          19
        4. group Id
          BG003
          lower Limit
          1
          upper Limit
          457
          value
          126
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Baseline Platelet
    unit Of Measure
    platelets x10^9/L
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          5
          value
          1.96
        2. group Id
          BG001
          lower Limit
          0
          upper Limit
          6
          value
          1.87
        3. group Id
          BG002
          lower Limit
          0
          upper Limit
          8
          value
          1.8
        4. group Id
          BG003
          lower Limit
          0
          upper Limit
          8
          value
          1.87
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Blast Count
    unit Of Measure
    percentage of blasts in bone marrow cell
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          49
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Myelodysplastic Syndrome (MDS)
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. 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
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Chronic Myelomonocytic Leukemia (CMML)
    unit Of Measure
    Participants
  10. 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
          1
        title
        Very Low Risk
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          24
        title
        Low Risk
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          27
        title
        Intermediate Risk
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Revised International Prognostic Scoring System (IPSS-R) for Myelodysplastic Syndrome (MDS)
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0
          upper Limit
          3
          value
          0.63
        2. group Id
          BG001
          lower Limit
          0
          upper Limit
          2
          value
          0.53
        3. group Id
          BG002
          lower Limit
          0
          upper Limit
          3
          value
          0.48
        4. group Id
          BG003
          lower Limit
          0
          upper Limit
          3
          value
          0.54
    dispersion Type
    FULL_RANGE
    param Type
    MEAN
    title
    Number of Prior Treatments
    unit Of Measure
    Prior Treatments

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