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NCT01566695 · BASELINE

Baseline characteristics

The Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Placebo and Best Supportive Care in Subjects With Red Blood Cell (RBC) Transfusion-Dependent Anemia and Thrombocytopenia Due to International Prognostic Scoring System (IPSS) Low Risk Myelodysplastic Syndrome (MDS) · Source last updated 2025-01-07

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
      107
    2. group Id
      BG001
      value
      109
    3. group Id
      BG002
      value
      216
    units
    Participants
groups
  1. description
    Participants received 300 mg oral azacitidine tablets daily (QD) on days 1 to 21 of each 28-day treatment cycle and best supportive care (BSC) which included and was not limited to packed RBC (packed red blood cell \[pRBC\] and whole blood), platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and granulocyte colony stimulating factors (G-CSF) for participants who experienced neutropenic fever/infections.
    id
    BG000
    title
    Oral Azacitidine Plus Best Supportive Care
  2. description
    Participants received identically matching placebo tablets QD on days 1 to 21 of each 28-day treatment cycle and BSC which included but was not limited to, pRBC and whole blood, platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and G-CSF for participants who experienced neutropenic fever/infections.
    id
    BG001
    title
    Placebo Plus Best Supportive Care
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.23
          value
          73.0
        2. group Id
          BG001
          spread
          8.36
          value
          73.1
        3. group Id
          BG002
          spread
          8.78
          value
          73.0
    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
          28
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          58
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          79
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          158
        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
          96
        2. group Id
          BG001
          value
          99
        3. group Id
          BG002
          value
          195
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islanders
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Japanese
      7. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          15
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          13
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          91
        2. group Id
          BG001
          value
          93
        3. group Id
          BG002
          value
          184
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          19
        title
        Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        title
        RA = Refractory Anemia
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        RN = Refractory Neutropenia
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        RT = Refractory Thrombocytopenia
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        RARS = RA with Ringed Sideroblasts
      5. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          73
        3. group Id
          BG002
          value
          153
        title
        RCMD = R Cytopenia w/ Multilineage Dysplasia
      6. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          46
        title
        RAEB-1 RA with Excess Blasts - 1
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        RAEB-2 RA with Excess Blasts - 2
      8. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        MDS-U (MDS-unclassified)
      9. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        del (5q) MDS Associated with Isolated del 5q
    description
    The WHO classification recognizes eight subtypes of MDS that are distinguished by the percentage of myeloblasts, presence or absence of ringed sideroblasts (i.e., erythroid precursors with iron deposits surrounding the nucleus), presence of a monocytosis or a deletion 5q.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Myelodysplastic Syndrome (MDS) World Health Organization (WHO) 2008 Classification
    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
        title
        Low
      2. measurements
        1. group Id
          BG000
          value
          106
        2. group Id
          BG001
          value
          109
        3. group Id
          BG002
          value
          215
        title
        Intermediate 1 (0.5-1.0)
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Intermediate 2 (1.5-2.0)
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        High
    description
    The international prognostic scoring system (IPSS) is a standard for risk assessment in primary myelodysplastic syndromes (MDS) that categorizes prognoses taking into account cytogenetics, cytopenias, blasts and blood counts. The IPSS prognostic subgroups consist of low-, intermediate-1-, intermediate-2-, and high-risk groups. The scale is 0-3.5 at 0.5 increments. Scores of 0=Low; 0.5-1.0=Int-1; 1.5-2.0=Int-2; 2.5-3.5=High risk which corresponds to poorer prognosis.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Prognostic Scoring System (IPSS)
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.3
          upper Limit
          10.0
          value
          3.33
        2. group Id
          BG001
          lower Limit
          1.3
          upper Limit
          9.5
          value
          3.33
        3. group Id
          BG002
          lower Limit
          1.3
          upper Limit
          10.0
          value
          3.33
    description
    The average red blood cell (RBC) transfusion units per 28 days is derived using transfusion records before randomization date to randomization date - 84 days (if enrolled under original protocol or protocol amendment 1), or to randomization date - 56 days (if enrolled under protocol 2).
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Average Red Blood Cell Transfusion Requirement (units per 28 days)
    unit Of Measure
    units per 28 days
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.988
          value
          8.22
        2. group Id
          BG001
          spread
          0.960
          value
          8.04
        3. group Id
          BG002
          spread
          0.976
          value
          8.13
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Hemoglobin
    unit Of Measure
    g/dL
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          15.97
          value
          27.0
        2. group Id
          BG001
          spread
          18.11
          value
          27.9
        3. group Id
          BG002
          spread
          17.05
          value
          27.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Platelet Count
    unit Of Measure
    10^9 cells/L
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          65
        title
        Dependent
      2. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          74
        3. group Id
          BG002
          value
          151
        title
        Independent
    description
    Participants with thrombocytopenia were defined by 2 platelet counts that were ≤ 75 × 10\^9/cells/L with a platelet measurement ≥ 21 days apart. For those who were platelet transfusion-dependent at baseline and did not achieve platelet transfusion independence (TI) ≥ 56 days (8 weeks) during study treatment were considered as non-responders. For participants who were not platelet transfusion-dependent at baseline, development of platelet transfusion dependence, ie, ≥ 2 platelet transfusions in any 56-day (8 week) period during study treatment and were considered worse outcome.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Platelet Transfusion Status
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          91
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          185
        title
        Grade 0-1
      2. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          31
        title
        Grade 2
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Grade 3
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Grade 4
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Grade 5
    description
    ECOG performance status is used to describe a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.). The scale ranges from 0 to 5: 0 = Fully active, no restrictions; 1 = Restricted activity but ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities; 3 = Capable to only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled, no self-care, confined to bed or chair; 5 = Dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
population Description
The intent-to-treat (ITT) population included all participants who were randomized, regardless of whether they received treatment or not.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      107
    2. group Id
      BG001
      value
      109
    3. group Id
      BG002
      value
      216
    units
    Participants
groups
  1. description
    Participants received 300 mg oral azacitidine tablets daily (QD) on days 1 to 21 of each 28-day treatment cycle and best supportive care (BSC) which included and was not limited to packed RBC (packed red blood cell \[pRBC\] and whole blood), platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and granulocyte colony stimulating factors (G-CSF) for participants who experienced neutropenic fever/infections.
    id
    BG000
    title
    Oral Azacitidine Plus Best Supportive Care
  2. description
    Participants received identically matching placebo tablets QD on days 1 to 21 of each 28-day treatment cycle and BSC which included but was not limited to, pRBC and whole blood, platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and G-CSF for participants who experienced neutropenic fever/infections.
    id
    BG001
    title
    Placebo Plus Best Supportive Care
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.23
          value
          73.0
        2. group Id
          BG001
          spread
          8.36
          value
          73.1
        3. group Id
          BG002
          spread
          8.78
          value
          73.0
    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
          28
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          58
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          79
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          158
        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
          96
        2. group Id
          BG001
          value
          99
        3. group Id
          BG002
          value
          195
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islanders
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Japanese
      7. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          15
        title
        Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          13
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          91
        2. group Id
          BG001
          value
          93
        3. group Id
          BG002
          value
          184
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          19
        title
        Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          7
        title
        RA = Refractory Anemia
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        RN = Refractory Neutropenia
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        RT = Refractory Thrombocytopenia
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        RARS = RA with Ringed Sideroblasts
      5. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          73
        3. group Id
          BG002
          value
          153
        title
        RCMD = R Cytopenia w/ Multilineage Dysplasia
      6. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          46
        title
        RAEB-1 RA with Excess Blasts - 1
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        RAEB-2 RA with Excess Blasts - 2
      8. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        MDS-U (MDS-unclassified)
      9. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        del (5q) MDS Associated with Isolated del 5q
    description
    The WHO classification recognizes eight subtypes of MDS that are distinguished by the percentage of myeloblasts, presence or absence of ringed sideroblasts (i.e., erythroid precursors with iron deposits surrounding the nucleus), presence of a monocytosis or a deletion 5q.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Myelodysplastic Syndrome (MDS) World Health Organization (WHO) 2008 Classification
    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
        title
        Low
      2. measurements
        1. group Id
          BG000
          value
          106
        2. group Id
          BG001
          value
          109
        3. group Id
          BG002
          value
          215
        title
        Intermediate 1 (0.5-1.0)
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Intermediate 2 (1.5-2.0)
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        High
    description
    The international prognostic scoring system (IPSS) is a standard for risk assessment in primary myelodysplastic syndromes (MDS) that categorizes prognoses taking into account cytogenetics, cytopenias, blasts and blood counts. The IPSS prognostic subgroups consist of low-, intermediate-1-, intermediate-2-, and high-risk groups. The scale is 0-3.5 at 0.5 increments. Scores of 0=Low; 0.5-1.0=Int-1; 1.5-2.0=Int-2; 2.5-3.5=High risk which corresponds to poorer prognosis.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Prognostic Scoring System (IPSS)
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          1.3
          upper Limit
          10.0
          value
          3.33
        2. group Id
          BG001
          lower Limit
          1.3
          upper Limit
          9.5
          value
          3.33
        3. group Id
          BG002
          lower Limit
          1.3
          upper Limit
          10.0
          value
          3.33
    description
    The average red blood cell (RBC) transfusion units per 28 days is derived using transfusion records before randomization date to randomization date - 84 days (if enrolled under original protocol or protocol amendment 1), or to randomization date - 56 days (if enrolled under protocol 2).
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Average Red Blood Cell Transfusion Requirement (units per 28 days)
    unit Of Measure
    units per 28 days
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.988
          value
          8.22
        2. group Id
          BG001
          spread
          0.960
          value
          8.04
        3. group Id
          BG002
          spread
          0.976
          value
          8.13
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Hemoglobin
    unit Of Measure
    g/dL
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          15.97
          value
          27.0
        2. group Id
          BG001
          spread
          18.11
          value
          27.9
        3. group Id
          BG002
          spread
          17.05
          value
          27.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Platelet Count
    unit Of Measure
    10^9 cells/L
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          30
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          65
        title
        Dependent
      2. measurements
        1. group Id
          BG000
          value
          77
        2. group Id
          BG001
          value
          74
        3. group Id
          BG002
          value
          151
        title
        Independent
    description
    Participants with thrombocytopenia were defined by 2 platelet counts that were ≤ 75 × 10\^9/cells/L with a platelet measurement ≥ 21 days apart. For those who were platelet transfusion-dependent at baseline and did not achieve platelet transfusion independence (TI) ≥ 56 days (8 weeks) during study treatment were considered as non-responders. For participants who were not platelet transfusion-dependent at baseline, development of platelet transfusion dependence, ie, ≥ 2 platelet transfusions in any 56-day (8 week) period during study treatment and were considered worse outcome.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Platelet Transfusion Status
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          91
        2. group Id
          BG001
          value
          94
        3. group Id
          BG002
          value
          185
        title
        Grade 0-1
      2. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          31
        title
        Grade 2
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Grade 3
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Grade 4
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Grade 5
    description
    ECOG performance status is used to describe a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.). The scale ranges from 0 to 5: 0 = Fully active, no restrictions; 1 = Restricted activity but ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities; 3 = Capable to only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled, no self-care, confined to bed or chair; 5 = Dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
population Description
The intent-to-treat (ITT) population included all participants who were randomized, regardless of whether they received treatment or not.

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