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NCT00652626 · BASELINE

Baseline characteristics

Pharmacokinetics and Safety Study of Azacitidine in Cancer Patients With and Without Impaired Renal Function · Source last updated 2019-11-19

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
      5
    2. group Id
      BG001
      value
      5
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      5
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      14
    7. group Id
      BG006
      value
      4
    8. group Id
      BG007
      value
      45
    units
    Participants
groups
  1. description
    Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
    id
    BG000
    title
    Azacitidine 25 mg/m^2
  2. description
    Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
    id
    BG001
    title
    Azacitidine 50 mg/m^2
  3. description
    Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
    id
    BG002
    title
    Azacitidine 75 mg/m^2
  4. description
    Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
    id
    BG003
    title
    Azacitidine 100 mg/m^2
  5. description
    Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
    id
    BG004
    title
    Severe RI: Azacitidine 75 mg/m^2
  6. description
    Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
    id
    BG005
    title
    Extension Phase: Normal RF
  7. description
    Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
    id
    BG006
    title
    Extension Phase: Severe RI
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.78
          value
          67.6
        2. group Id
          BG001
          spread
          9.63
          value
          64.6
        3. group Id
          BG002
          spread
          10.19
          value
          53.5
        4. group Id
          BG003
          spread
          12.02
          value
          57.0
        5. group Id
          BG004
          spread
          12.58
          value
          74.5
        6. comment
          Data for provided initial treatment period arms only
          group Id
          BG005
          spread
          NA
          value
          NA
        7. comment
          Data provided for initial treatment period arms only
          group Id
          BG006
          spread
          NA
          value
          NA
        8. group Id
          BG007
          spread
          12.32
          value
          63.5
      title
      Initial Treatment Period
    2. categories
      1. measurements
        1. comment
          Data provided for extension treatment period arms only
          group Id
          BG000
          spread
          NA
          value
          NA
        2. comment
          Data provided for extension treatment period arms only
          group Id
          BG001
          spread
          NA
          value
          NA
        3. comment
          Data provided for extension treatment period arms only
          group Id
          BG002
          spread
          NA
          value
          NA
        4. comment
          Data provided for extension treatment period arms only
          group Id
          BG003
          spread
          NA
          value
          NA
        5. comment
          Data provided for extension treatment period arms only
          group Id
          BG004
          spread
          NA
          value
          NA
        6. group Id
          BG005
          spread
          9.52
          value
          60.6
        7. group Id
          BG006
          spread
          11.0
          value
          68.8
        8. group Id
          BG007
          spread
          10.15
          value
          62.4
      title
      Extension Treatment Period
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          16
      title
      Female
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          11
      title
      Male
    description
    Data provided for initial treatment phase groups only.
    param Type
    NUMBER
    title
    Sex/Gender, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          8
      title
      Black
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          19
      title
      White
    description
    Data provided for initial treatment phase groups only.
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          27
      title
      United States
    description
    Data provided for initial treatment phase groups only.
    param Type
    NUMBER
    title
    Region of Enrollment
    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
          8
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          10
      title
      Female
    2. 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
          6
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          8
      title
      Male
    param Type
    NUMBER
    title
    Gender of Extension Period Participants
    unit Of Measure
    participants
  6. 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
          5
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          5
      title
      Black
    2. 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
          9
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          13
      title
      White
    param Type
    NUMBER
    title
    Race: Extension Phase
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          7
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          18
      title
      1
    3. 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
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
      title
      2
    description
    Scale used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. 0 = fully active, no restrictions; 1 = restricted but ambulatory and capable of light work; 2 = ambulatory and capable of self-care but unable to work. 3 = Capable of only limited self care, confined to bed or chair more than 50% of waking hours. 4 = Completely disabled. Cannot carry on any self care. Totally confined to bed or chair. 5 = Dead.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status: Initial Treatment Phase
    unit Of Measure
    participants
  8. 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
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          3
      title
      0
    2. 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
          11
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          14
      title
      1
    3. 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
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      2
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status: Extension Phase
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.20
          value
          2.0
        2. group Id
          BG001
          spread
          0.28
          value
          1.9
        3. group Id
          BG002
          spread
          0.42
          value
          1.9
        4. group Id
          BG003
          spread
          0.15
          value
          1.6
        5. group Id
          BG004
          spread
          0.15
          value
          1.8
        6. comment
          Data provided for initial treatment period arms only
          group Id
          BG005
          spread
          NA
          value
          NA
        7. comment
          Data provided for initial treatment period arms only
          group Id
          BG006
          spread
          NA
          value
          NA
        8. group Id
          BG007
          spread
          0.27
          value
          1.9
      title
      Initial Treatment Period
    2. categories
      1. measurements
        1. comment
          Data provided for extension treatment period arms only
          group Id
          BG000
          spread
          NA
          value
          NA
        2. comment
          Data provided for extension treatment period arms only
          group Id
          BG001
          spread
          NA
          value
          NA
        3. comment
          Data provided for extension treatment period arms only
          group Id
          BG002
          spread
          NA
          value
          NA
        4. comment
          Data provided for extension treatment period arms only
          group Id
          BG003
          spread
          NA
          value
          NA
        5. comment
          Data provided for extension treatment period arms only
          group Id
          BG004
          spread
          NA
          value
          NA
        6. group Id
          BG005
          spread
          0.35
          value
          1.9
        7. group Id
          BG006
          spread
          0.06
          value
          1.9
        8. group Id
          BG007
          spread
          0.31
          value
          1.9
      title
      Extension Period
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Surface Area (BSA)
    unit Of Measure
    m^2
  10. classes
    1. categories
      1. 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
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
      title
      Myelodysplastic syndrome-RA
    2. 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
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      Myelodysplastic syndrome-RARS
    3. 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
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
      title
      Myelodysplastic syndrome-RAEB-T
    4. 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
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      Chronic myelomonocytic leukemia
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          20
      title
      Solid tumor
    6. 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
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      Multiple myeloma
    description
    MDS = myelodysplastic syndrome; MM = multiple myeloma; RA = refractory anemia; RAEB-T = refractory anemia with excess blasts in transformation; RARS = refractory anemia with ringed sideroblasts; CMML = chronic myelomonocytic leukemia.
    param Type
    NUMBER
    title
    Cancer Diagnosis: Initial Treatment Phase
    unit Of Measure
    participants
  11. 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
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
      title
      Myelodysplastic syndrome-RA
    2. 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
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      Myelodysplastic syndrome-RARS
    3. 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
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      Myelodysplastic syndrome-RAEB-T
    4. 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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
      title
      Chronic myelomonocytic leukemia
    5. 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
          12
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          15
      title
      Solid tumor
    6. 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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
      title
      Multiple myeloma
    param Type
    NUMBER
    title
    Cancer Diagnosis: Extension Phase
    unit Of Measure
    participants
population Description
Safety population. The total number of participants in the study was 27; 18 continued treatment in the extension phase.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      5
    2. group Id
      BG001
      value
      5
    3. group Id
      BG002
      value
      6
    4. group Id
      BG003
      value
      5
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      14
    7. group Id
      BG006
      value
      4
    8. group Id
      BG007
      value
      45
    units
    Participants
groups
  1. description
    Participants with normal renal function (defined as creatinine clearance \> 80 mL/min/1.73m\^2) received a single subcutaneous dose of azacitidine 25 mg/m\^2 on Day 1.
    id
    BG000
    title
    Azacitidine 25 mg/m^2
  2. description
    Participants with normal renal function received a single subcutaneous dose of azacitidine 50 mg/m\^2 on Day 1.
    id
    BG001
    title
    Azacitidine 50 mg/m^2
  3. description
    Participants with normal renal function received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
    id
    BG002
    title
    Azacitidine 75 mg/m^2
  4. description
    Participants with normal renal function received a single subcutaneous dose of azacitidine 100 mg/m\^2 on Day 1.
    id
    BG003
    title
    Azacitidine 100 mg/m^2
  5. description
    Participants with severe renal impairment (RI; defined as creatinine clearance \< 30 mL/min/1.73 m\^2) received subcutaneous doses of azacitidine 75 mg/m\^2 on Days 1 to 5.
    id
    BG004
    title
    Severe RI: Azacitidine 75 mg/m^2
  6. description
    Participants with normal renal function (RF) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
    id
    BG005
    title
    Extension Phase: Normal RF
  7. description
    Participants with severe renal impairment (RI) received up to 6 cycles of treatment with 75 mg/m\^2 azacitidine daily on Days 1-7 of each 28-day cycle.
    id
    BG006
    title
    Extension Phase: Severe RI
  8. description
    Total of all reporting groups
    id
    BG007
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          3.78
          value
          67.6
        2. group Id
          BG001
          spread
          9.63
          value
          64.6
        3. group Id
          BG002
          spread
          10.19
          value
          53.5
        4. group Id
          BG003
          spread
          12.02
          value
          57.0
        5. group Id
          BG004
          spread
          12.58
          value
          74.5
        6. comment
          Data for provided initial treatment period arms only
          group Id
          BG005
          spread
          NA
          value
          NA
        7. comment
          Data provided for initial treatment period arms only
          group Id
          BG006
          spread
          NA
          value
          NA
        8. group Id
          BG007
          spread
          12.32
          value
          63.5
      title
      Initial Treatment Period
    2. categories
      1. measurements
        1. comment
          Data provided for extension treatment period arms only
          group Id
          BG000
          spread
          NA
          value
          NA
        2. comment
          Data provided for extension treatment period arms only
          group Id
          BG001
          spread
          NA
          value
          NA
        3. comment
          Data provided for extension treatment period arms only
          group Id
          BG002
          spread
          NA
          value
          NA
        4. comment
          Data provided for extension treatment period arms only
          group Id
          BG003
          spread
          NA
          value
          NA
        5. comment
          Data provided for extension treatment period arms only
          group Id
          BG004
          spread
          NA
          value
          NA
        6. group Id
          BG005
          spread
          9.52
          value
          60.6
        7. group Id
          BG006
          spread
          11.0
          value
          68.8
        8. group Id
          BG007
          spread
          10.15
          value
          62.4
      title
      Extension Treatment Period
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          16
      title
      Female
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          11
      title
      Male
    description
    Data provided for initial treatment phase groups only.
    param Type
    NUMBER
    title
    Sex/Gender, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          8
      title
      Black
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          19
      title
      White
    description
    Data provided for initial treatment phase groups only.
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          27
      title
      United States
    description
    Data provided for initial treatment phase groups only.
    param Type
    NUMBER
    title
    Region of Enrollment
    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
          8
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          10
      title
      Female
    2. 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
          6
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          8
      title
      Male
    param Type
    NUMBER
    title
    Gender of Extension Period Participants
    unit Of Measure
    participants
  6. 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
          5
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          5
      title
      Black
    2. 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
          9
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          13
      title
      White
    param Type
    NUMBER
    title
    Race: Extension Phase
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          7
      title
      0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          18
      title
      1
    3. 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
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
      title
      2
    description
    Scale used by doctors and researchers to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. 0 = fully active, no restrictions; 1 = restricted but ambulatory and capable of light work; 2 = ambulatory and capable of self-care but unable to work. 3 = Capable of only limited self care, confined to bed or chair more than 50% of waking hours. 4 = Completely disabled. Cannot carry on any self care. Totally confined to bed or chair. 5 = Dead.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status: Initial Treatment Phase
    unit Of Measure
    participants
  8. 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
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          3
      title
      0
    2. 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
          11
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          14
      title
      1
    3. 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
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      2
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status: Extension Phase
    unit Of Measure
    participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.20
          value
          2.0
        2. group Id
          BG001
          spread
          0.28
          value
          1.9
        3. group Id
          BG002
          spread
          0.42
          value
          1.9
        4. group Id
          BG003
          spread
          0.15
          value
          1.6
        5. group Id
          BG004
          spread
          0.15
          value
          1.8
        6. comment
          Data provided for initial treatment period arms only
          group Id
          BG005
          spread
          NA
          value
          NA
        7. comment
          Data provided for initial treatment period arms only
          group Id
          BG006
          spread
          NA
          value
          NA
        8. group Id
          BG007
          spread
          0.27
          value
          1.9
      title
      Initial Treatment Period
    2. categories
      1. measurements
        1. comment
          Data provided for extension treatment period arms only
          group Id
          BG000
          spread
          NA
          value
          NA
        2. comment
          Data provided for extension treatment period arms only
          group Id
          BG001
          spread
          NA
          value
          NA
        3. comment
          Data provided for extension treatment period arms only
          group Id
          BG002
          spread
          NA
          value
          NA
        4. comment
          Data provided for extension treatment period arms only
          group Id
          BG003
          spread
          NA
          value
          NA
        5. comment
          Data provided for extension treatment period arms only
          group Id
          BG004
          spread
          NA
          value
          NA
        6. group Id
          BG005
          spread
          0.35
          value
          1.9
        7. group Id
          BG006
          spread
          0.06
          value
          1.9
        8. group Id
          BG007
          spread
          0.31
          value
          1.9
      title
      Extension Period
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Surface Area (BSA)
    unit Of Measure
    m^2
  10. classes
    1. categories
      1. 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
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
      title
      Myelodysplastic syndrome-RA
    2. 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
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      Myelodysplastic syndrome-RARS
    3. 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
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          2
      title
      Myelodysplastic syndrome-RAEB-T
    4. 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
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      Chronic myelomonocytic leukemia
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          20
      title
      Solid tumor
    6. 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
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      Multiple myeloma
    description
    MDS = myelodysplastic syndrome; MM = multiple myeloma; RA = refractory anemia; RAEB-T = refractory anemia with excess blasts in transformation; RARS = refractory anemia with ringed sideroblasts; CMML = chronic myelomonocytic leukemia.
    param Type
    NUMBER
    title
    Cancer Diagnosis: Initial Treatment Phase
    unit Of Measure
    participants
  11. 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
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
      title
      Myelodysplastic syndrome-RA
    2. 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
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      Myelodysplastic syndrome-RARS
    3. 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
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
      title
      Myelodysplastic syndrome-RAEB-T
    4. 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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
      title
      Chronic myelomonocytic leukemia
    5. 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
          12
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          15
      title
      Solid tumor
    6. 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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
      title
      Multiple myeloma
    param Type
    NUMBER
    title
    Cancer Diagnosis: Extension Phase
    unit Of Measure
    participants
population Description
Safety population. The total number of participants in the study was 27; 18 continued treatment in the extension phase.

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Preserved source evidence · Not medical advice