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NCT01074047 · BASELINE

Baseline characteristics

Study of Vidaza Versus Conventional Care Regimens for the Treatment of Acute Myeloid Leukemia (AML) · Source last updated 2017-08-29

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
      241
    2. group Id
      BG001
      value
      247
    3. group Id
      BG002
      value
      488
    units
    Participants
groups
  1. description
    Azacitidine 75 mg/m2/day by subcutaneous injection \[SC\] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
    id
    BG000
    title
    Azacitidine (AZA)
  2. description
    #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m\^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m\^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m\^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m\^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m\^² QD or Idarubicin 9-12 mg/m\^² IV QD on Days 1 and 2. Consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10\^9/L and platelets above 75 x 10\^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed. # 2 Low-dose cytarabine 20 mg SC twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only includes transfusion of blood products, antibiotics, antifungals and nutritional help.
    id
    BG001
    title
    Conventional Care Regimens (CCR)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.60
          value
          75.4
        2. group Id
          BG001
          spread
          5.57
          value
          75.1
        3. group Id
          BG002
          spread
          5.58
          value
          75.2
    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
          103
        2. group Id
          BG001
          value
          120
        3. group Id
          BG002
          value
          223
      title
      <75 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          138
        2. group Id
          BG001
          value
          127
        3. group Id
          BG002
          value
          265
      title
      ≥75 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          102
        2. group Id
          BG001
          value
          98
        3. group Id
          BG002
          value
          200
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          139
        2. group Id
          BG001
          value
          149
        3. group Id
          BG002
          value
          288
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          111
      title
      0 = Fully Active
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          132
        3. group Id
          BG002
          value
          264
      title
      1 = Restrictive but Ambulatory
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          55
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          113
      title
      2 = Ambulatory but unable to work
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      3 = Limited Self Care
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      4 = Completely disabled
    description
    ECOG performance status is used by doctors and researchers to assess how a participants disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity), 1 = Restricted activity but ambulatory, 2 = Ambulatory but unable to carry out work activities, 3 = Limited Self Care; 4 = Completely Disabled, No self care (Least Favorable Activity)
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          75
        2. group Id
          BG001
          value
          83
        3. group Id
          BG002
          value
          158
      title
      AML with myelodysplasia-related changes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          158
      title
      Therapy-related myeloid neoplasms
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          14
      title
      AML with recurrent genetic abnormalities
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          153
        2. group Id
          BG001
          value
          143
        3. group Id
          BG002
          value
          296
      title
      AML not otherwise specified
    description
    WHO categories include: 1. Those with AML with recurrent genetic abnormalities. Includes subtypes with multiple chromosome translocations and mutations. 2. Those with AML with myelodysplasia-related changes. Includes those with prior myelodysplastic syndrome (MDS) or myeloproliferative disease and has transformed to AML. 3. Those with therapy related myeloid neoplasms and have had prior chemotherapy and/or radiation and subsequently develop AML or MDS 4. Those with AML not otherwise specified and include subtypes that do not fall into the above categories.
    param Type
    NUMBER
    title
    World Health Organization Acute Myeloid Leukemia (AML) Classification
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          24.71
          value
          66.6
        2. group Id
          BG001
          spread
          22.28
          value
          70.2
        3. group Id
          BG002
          spread
          23.56
          value
          68.5
    description
    Baseline clinical characteristics, including percentage of bone marrow blasts were assessed centrally and locally. Central values are included here. Baseline blasts were the last non-missing value on or prior to the date of randomization. The bone marrow blasts cells are not typically found in the circulating blood of healthy individuals. Abnormal immature white blood cells (blasts) fill the bone marrow and spill into the bloodstream.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Bone Marrow-Blasts Counts
    unit Of Measure
    Percentage of Bone Marrow Blasts
population Description
The intent-to-treat (ITT) population is defined as all participants who were randomized, independent of whether they received study treatment or not.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      241
    2. group Id
      BG001
      value
      247
    3. group Id
      BG002
      value
      488
    units
    Participants
groups
  1. description
    Azacitidine 75 mg/m2/day by subcutaneous injection \[SC\] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
    id
    BG000
    title
    Azacitidine (AZA)
  2. description
    #1 Intensive Chemotherapy: Cytarabine 100-200 mg/m\^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m\^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m\^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m\^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m\^² QD or Idarubicin 9-12 mg/m\^² IV QD on Days 1 and 2. Consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10\^9/L and platelets above 75 x 10\^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed. # 2 Low-dose cytarabine 20 mg SC twice a day (BID) for 10 days every 28 days, plus BSC # 3 BSC only includes transfusion of blood products, antibiotics, antifungals and nutritional help.
    id
    BG001
    title
    Conventional Care Regimens (CCR)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.60
          value
          75.4
        2. group Id
          BG001
          spread
          5.57
          value
          75.1
        3. group Id
          BG002
          spread
          5.58
          value
          75.2
    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
          103
        2. group Id
          BG001
          value
          120
        3. group Id
          BG002
          value
          223
      title
      <75 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          138
        2. group Id
          BG001
          value
          127
        3. group Id
          BG002
          value
          265
      title
      ≥75 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          102
        2. group Id
          BG001
          value
          98
        3. group Id
          BG002
          value
          200
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          139
        2. group Id
          BG001
          value
          149
        3. group Id
          BG002
          value
          288
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          111
      title
      0 = Fully Active
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          132
        3. group Id
          BG002
          value
          264
      title
      1 = Restrictive but Ambulatory
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          55
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          113
      title
      2 = Ambulatory but unable to work
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      3 = Limited Self Care
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      4 = Completely disabled
    description
    ECOG performance status is used by doctors and researchers to assess how a participants disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity), 1 = Restricted activity but ambulatory, 2 = Ambulatory but unable to carry out work activities, 3 = Limited Self Care; 4 = Completely Disabled, No self care (Least Favorable Activity)
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          75
        2. group Id
          BG001
          value
          83
        3. group Id
          BG002
          value
          158
      title
      AML with myelodysplasia-related changes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          158
      title
      Therapy-related myeloid neoplasms
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          14
      title
      AML with recurrent genetic abnormalities
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          153
        2. group Id
          BG001
          value
          143
        3. group Id
          BG002
          value
          296
      title
      AML not otherwise specified
    description
    WHO categories include: 1. Those with AML with recurrent genetic abnormalities. Includes subtypes with multiple chromosome translocations and mutations. 2. Those with AML with myelodysplasia-related changes. Includes those with prior myelodysplastic syndrome (MDS) or myeloproliferative disease and has transformed to AML. 3. Those with therapy related myeloid neoplasms and have had prior chemotherapy and/or radiation and subsequently develop AML or MDS 4. Those with AML not otherwise specified and include subtypes that do not fall into the above categories.
    param Type
    NUMBER
    title
    World Health Organization Acute Myeloid Leukemia (AML) Classification
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          24.71
          value
          66.6
        2. group Id
          BG001
          spread
          22.28
          value
          70.2
        3. group Id
          BG002
          spread
          23.56
          value
          68.5
    description
    Baseline clinical characteristics, including percentage of bone marrow blasts were assessed centrally and locally. Central values are included here. Baseline blasts were the last non-missing value on or prior to the date of randomization. The bone marrow blasts cells are not typically found in the circulating blood of healthy individuals. Abnormal immature white blood cells (blasts) fill the bone marrow and spill into the bloodstream.
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Bone Marrow-Blasts Counts
    unit Of Measure
    Percentage of Bone Marrow Blasts
population Description
The intent-to-treat (ITT) population is defined as all participants who were randomized, independent of whether they received study treatment or not.

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Preserved source evidence · Not medical advice