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NCT03416374 · BASELINE

Baseline characteristics

A Study to Evaluate the Efficacy and Safety of Ixazomib in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Initially Treated With an Injection of Proteasome Inhibitor-Based Therapy · Source last updated 2022-09-27

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
      6
    2. group Id
      BG001
      value
      39
    3. group Id
      BG002
      value
      45
    units
    Participants
groups
  1. description
    Bortezomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)
    id
    BG000
    title
    [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy
  2. description
    Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)
    id
    BG001
    title
    [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.57
          value
          71.8
        2. group Id
          BG001
          spread
          9.40
          value
          70.5
        3. group Id
          BG002
          spread
          9.21
          value
          70.7
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          21
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          24
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG002
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Japan
    description
    All participants were enrolled in Japan.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.70
          value
          153.0
        2. group Id
          BG001
          spread
          8.29
          value
          158.5
        3. group Id
          BG002
          spread
          8.58
          value
          157.8
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    Centimeters (cm)
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.204
          value
          52.85
        2. group Id
          BG001
          spread
          10.380
          value
          57.87
        3. group Id
          BG002
          spread
          10.081
          value
          57.17
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          43
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The number analyzed is the number of participants with data available for analysis.
    title
    Weight
    unit Of Measure
    Kilograms (kg)
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          2.619
          value
          22.60
        2. group Id
          BG001
          spread
          2.512
          value
          22.91
        3. group Id
          BG002
          spread
          2.497
          value
          22.86
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          43
        units
        Participants
    description
    Body Mass Index = weight (kg)/\[height (m)\^2\]
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The number analyzed is the number of participants with data available for analysis.
    title
    BMI
    unit Of Measure
    Kilogram (kg)/meter (m)^2]
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.1395
          value
          1.487
        2. group Id
          BG001
          spread
          0.1760
          value
          1.583
        3. group Id
          BG002
          spread
          0.1732
          value
          1.569
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          43
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The number analyzed is the number of participants with data available for analysis.
    title
    Body Surface Area
    unit Of Measure
    m^2
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          19
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          17
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          9
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Stage III
    description
    International Staging System is a staging system for cancer progression. Stages are classified by Stage I to Stage III. Stage I: Serum beta2-microglobulin \<3.5 mg/L and albumin ≥3.5 g/dL; Stage II: Neither Stage I or III, meaning that either: beta2-microglobulin level ≥3.5 and \<5.5 mg/L (with any albumin level), OR albumin \<3.5 g/dL with beta2-microglobulin \<3.5 mg/L; Stage III: Serum beta2-microglobulin ≥5.5 mg/L. Normal serum beta2-microglobulin: \<3.0 mg/L; normal albumin: 3.5-5.0 g/dL.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Staging System (at Initial Diagnosis)
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          24
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          13
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Stage III
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Staging System (at First Treatment [Period I])
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          33
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Scale = 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          10
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Scale = 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Scale = 2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Scale = 3
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Scale = 4
    description
    ECOG P.S.) assess participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory ( greater than \[\>\] 50 percent \[%\] of waking hours), capable of all self-care, unable to carry out any work activities; 3=capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group performance status (ECOG P.S.)
    unit Of Measure
    Participants
population Description
Full Analysis Set (FAS): all participants who were enrolled in Treatment Period I and who receive at least one dose of any therapy during the Treatment Period.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      6
    2. group Id
      BG001
      value
      39
    3. group Id
      BG002
      value
      45
    units
    Participants
groups
  1. description
    Bortezomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)
    id
    BG000
    title
    [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy
  2. description
    Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)
    id
    BG001
    title
    [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.57
          value
          71.8
        2. group Id
          BG001
          spread
          9.40
          value
          70.5
        3. group Id
          BG002
          spread
          9.21
          value
          70.7
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          21
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          24
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG002
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Japan
    description
    All participants were enrolled in Japan.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.70
          value
          153.0
        2. group Id
          BG001
          spread
          8.29
          value
          158.5
        3. group Id
          BG002
          spread
          8.58
          value
          157.8
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    Centimeters (cm)
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.204
          value
          52.85
        2. group Id
          BG001
          spread
          10.380
          value
          57.87
        3. group Id
          BG002
          spread
          10.081
          value
          57.17
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          43
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The number analyzed is the number of participants with data available for analysis.
    title
    Weight
    unit Of Measure
    Kilograms (kg)
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          2.619
          value
          22.60
        2. group Id
          BG001
          spread
          2.512
          value
          22.91
        3. group Id
          BG002
          spread
          2.497
          value
          22.86
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          43
        units
        Participants
    description
    Body Mass Index = weight (kg)/\[height (m)\^2\]
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The number analyzed is the number of participants with data available for analysis.
    title
    BMI
    unit Of Measure
    Kilogram (kg)/meter (m)^2]
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.1395
          value
          1.487
        2. group Id
          BG001
          spread
          0.1760
          value
          1.583
        3. group Id
          BG002
          spread
          0.1732
          value
          1.569
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          43
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The number analyzed is the number of participants with data available for analysis.
    title
    Body Surface Area
    unit Of Measure
    m^2
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          19
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          17
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          9
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Stage III
    description
    International Staging System is a staging system for cancer progression. Stages are classified by Stage I to Stage III. Stage I: Serum beta2-microglobulin \<3.5 mg/L and albumin ≥3.5 g/dL; Stage II: Neither Stage I or III, meaning that either: beta2-microglobulin level ≥3.5 and \<5.5 mg/L (with any albumin level), OR albumin \<3.5 g/dL with beta2-microglobulin \<3.5 mg/L; Stage III: Serum beta2-microglobulin ≥5.5 mg/L. Normal serum beta2-microglobulin: \<3.0 mg/L; normal albumin: 3.5-5.0 g/dL.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Staging System (at Initial Diagnosis)
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          24
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          13
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          5
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Stage III
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Staging System (at First Treatment [Period I])
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          33
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Scale = 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          10
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Scale = 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Scale = 2
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Scale = 3
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      denoms
      1. counts
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          45
        units
        Participants
      title
      Scale = 4
    description
    ECOG P.S.) assess participant's performance status on 5 point scale: 0=Fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory ( greater than \[\>\] 50 percent \[%\] of waking hours), capable of all self-care, unable to carry out any work activities; 3=capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair; 5=dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group performance status (ECOG P.S.)
    unit Of Measure
    Participants
population Description
Full Analysis Set (FAS): all participants who were enrolled in Treatment Period I and who receive at least one dose of any therapy during the Treatment Period.

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Preserved source evidence · Not medical advice