Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01757535 · BASELINE

Baseline characteristics

Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission · Source last updated 2025-07-08

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
      238
    2. group Id
      BG001
      value
      234
    3. group Id
      BG002
      value
      472
    units
    Participants
groups
  1. description
    Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.
    id
    BG000
    title
    Oral Azacitidine Plus Best Supportive Care
  2. description
    Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.
    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
          5.72
          value
          67.9
        2. group Id
          BG001
          spread
          5.62
          value
          68.0
        3. group Id
          BG002
          spread
          5.66
          value
          67.9
    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
          66
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          134
        title
        18 to 64 Years
      2. measurements
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          166
        3. group Id
          BG002
          value
          337
        title
        65 to 84 Years
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        ≥ 85 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          120
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          227
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          127
        3. group Id
          BG002
          value
          245
        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
          20
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          34
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          196
        2. group Id
          BG001
          value
          202
        3. group Id
          BG002
          value
          398
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          40
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          216
        2. group Id
          BG001
          value
          197
        3. group Id
          BG002
          value
          413
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          8
        title
        Black or African-American
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          26
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          23
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          85
        title
        AML with Recurrent Genetic Abnormalities
      2. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          91
        title
        AML with Myelodysplasia - Related Changes
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Therapy-related Myeloid Neoplasms
      4. measurements
        1. group Id
          BG000
          value
          148
        2. group Id
          BG001
          value
          145
        3. group Id
          BG002
          value
          293
        title
        AML not Otherwise Specified
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Missing
    description
    AML is classified using the WHO classification system based upon a combination of morphology, immunophenotype, genetics, and clinical features. There are several broad groups and include: 1. AML with genetic abnormalities; 2. AML with multilineage dysplasia 3. AML related to previous chemotherapy or radiation 4. Unspecified AML - do not fall into the above groups
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Initial Acute Myeloid Leukemia (AML) Classification
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          213
        2. group Id
          BG001
          value
          216
        3. group Id
          BG002
          value
          429
        title
        Primary (de novo)
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          43
        title
        Secondary
    description
    Primary AML is a cancer that originates in the blood and bone marrow. AML affects a group of white blood cells called myeloid cells, which normally develop into the various types of mature blood cells, such as red blood cells, white blood cells and platelets. Secondary acute myeloid leukemia (s-AML) refers to a leukemic process: (1) evolving from prior myelodysplasia (MDS), myeloproliferative disorder (MPN), or aplastic anemia (AA) with or without treatment or (2) as a product of previous exposure to a proven leukemogenic chemotherapeutic agent (therapy-related AML \[t-AML\]).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Type of Acute Myeloid Leukemia (AML)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          203
        2. group Id
          BG001
          value
          203
        3. group Id
          BG002
          value
          406
        title
        Intermediate
      2. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          66
        title
        Poor
    description
    Cytogenetic Risk - Intermediate -I is of a normal karyotype; Poor Risk - includes complex karyotypes having 3 or more cytogenetic abnormalities.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cytogenetic Risk Category at Diagnosis
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          116
        2. group Id
          BG001
          value
          111
        3. group Id
          BG002
          value
          227
        title
        Grade 0
      2. measurements
        1. group Id
          BG000
          value
          101
        2. group Id
          BG001
          value
          106
        3. group Id
          BG002
          value
          207
        title
        Grade 1
      3. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          36
        title
        Grade 2
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Grade 3
    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 includes participants who were randomized, regardless of whether they received treatment or not.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      238
    2. group Id
      BG001
      value
      234
    3. group Id
      BG002
      value
      472
    units
    Participants
groups
  1. description
    Participants received 300 mg azacitidine tablets once a day (QD) for the first 14 days of each 28-day treatment cycle until discontinuation, which includes the following reasons: disease relapse, withdrawal of consent, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, death, lost to follow-up, or protocol violation or until the end of the study.
    id
    BG000
    title
    Oral Azacitidine Plus Best Supportive Care
  2. description
    Participants received identically matching placebo tablets QD for the first 14 days of each 28-day treatment cycle until no longer receiving benefit, withdrawal of consent, disease relapse, adverse events, participant became eligible for allogeneic bone marrow or stem cell transplantation during the treatment period, lost to follow-up, or protocol violation or until the end of the study.
    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
          5.72
          value
          67.9
        2. group Id
          BG001
          spread
          5.62
          value
          68.0
        3. group Id
          BG002
          spread
          5.66
          value
          67.9
    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
          66
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          134
        title
        18 to 64 Years
      2. measurements
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          166
        3. group Id
          BG002
          value
          337
        title
        65 to 84 Years
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        ≥ 85 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          120
        2. group Id
          BG001
          value
          107
        3. group Id
          BG002
          value
          227
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          127
        3. group Id
          BG002
          value
          245
        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
          20
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          34
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          196
        2. group Id
          BG001
          value
          202
        3. group Id
          BG002
          value
          398
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          40
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          216
        2. group Id
          BG001
          value
          197
        3. group Id
          BG002
          value
          413
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          8
        title
        Black or African-American
      3. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          26
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          23
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          39
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          85
        title
        AML with Recurrent Genetic Abnormalities
      2. measurements
        1. group Id
          BG000
          value
          49
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          91
        title
        AML with Myelodysplasia - Related Changes
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Therapy-related Myeloid Neoplasms
      4. measurements
        1. group Id
          BG000
          value
          148
        2. group Id
          BG001
          value
          145
        3. group Id
          BG002
          value
          293
        title
        AML not Otherwise Specified
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Missing
    description
    AML is classified using the WHO classification system based upon a combination of morphology, immunophenotype, genetics, and clinical features. There are several broad groups and include: 1. AML with genetic abnormalities; 2. AML with multilineage dysplasia 3. AML related to previous chemotherapy or radiation 4. Unspecified AML - do not fall into the above groups
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Initial Acute Myeloid Leukemia (AML) Classification
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          213
        2. group Id
          BG001
          value
          216
        3. group Id
          BG002
          value
          429
        title
        Primary (de novo)
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          43
        title
        Secondary
    description
    Primary AML is a cancer that originates in the blood and bone marrow. AML affects a group of white blood cells called myeloid cells, which normally develop into the various types of mature blood cells, such as red blood cells, white blood cells and platelets. Secondary acute myeloid leukemia (s-AML) refers to a leukemic process: (1) evolving from prior myelodysplasia (MDS), myeloproliferative disorder (MPN), or aplastic anemia (AA) with or without treatment or (2) as a product of previous exposure to a proven leukemogenic chemotherapeutic agent (therapy-related AML \[t-AML\]).
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Type of Acute Myeloid Leukemia (AML)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          203
        2. group Id
          BG001
          value
          203
        3. group Id
          BG002
          value
          406
        title
        Intermediate
      2. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          66
        title
        Poor
    description
    Cytogenetic Risk - Intermediate -I is of a normal karyotype; Poor Risk - includes complex karyotypes having 3 or more cytogenetic abnormalities.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cytogenetic Risk Category at Diagnosis
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          116
        2. group Id
          BG001
          value
          111
        3. group Id
          BG002
          value
          227
        title
        Grade 0
      2. measurements
        1. group Id
          BG000
          value
          101
        2. group Id
          BG001
          value
          106
        3. group Id
          BG002
          value
          207
        title
        Grade 1
      3. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          36
        title
        Grade 2
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Grade 3
    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 includes participants who were randomized, regardless of whether they received treatment or not.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice