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NCT03306264 · BASELINE

Baseline characteristics

Study of ASTX727 vs IV Decitabine in Participants With MDS, CMML, and AML · Source last updated 2024-08-27

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
      133
    2. group Id
      BG001
      value
      87
    3. group Id
      BG002
      value
      220
    units
    Participants
groups
  1. description
    Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 2 or the converse. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
    id
    BG000
    title
    MDS or CMML: ASTX727 or IV Decitabine
  2. description
    Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 2 or the converse. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
    id
    BG001
    title
    AML: ASTX727 or IV Decitabine
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          39
      title
      18 to 64 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          93
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          168
      title
      65 to 84 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          13
      title
      ≥85 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          80
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          87
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          140
        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
          6
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          6
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          125
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          125
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          87
        3. group Id
          BG002
          value
          89
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. 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
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        title
        Asian
      3. 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 Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          121
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          121
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          87
        3. group Id
          BG002
          value
          92
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
The Safety Analysis Set included all participants who received any amount of study treatment.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      133
    2. group Id
      BG001
      value
      87
    3. group Id
      BG002
      value
      220
    units
    Participants
groups
  1. description
    Participants with MDS or CMML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 2 or the converse. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, treatment discontinuation for other reasons, or withdrawal from the study.
    id
    BG000
    title
    MDS or CMML: ASTX727 or IV Decitabine
  2. description
    Participants with AML received ASTX727 tablet, containing the fixed-dose combination of 35 mg decitabine and 100 mg cedazuridine, orally, once daily, on Days 1 to 5 in cycle 1 (each cycle = 28 days), followed by IV infusion of decitabine 20 mg/m\^2, once daily, on Days 1 to 5 in cycle 2 or the converse. A washout period of 23 days was maintained between the 2 cycles. From cycle 3, all participants enrolled in cycles 1 and 2 received ASTX727 tablet, once daily, on Days 1 to 5 of each 28-day cycle until disease progression, unacceptable toxicity, participant discontinued treatment, or was withdrawn from the study.
    id
    BG001
    title
    AML: ASTX727 or IV Decitabine
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          39
      title
      18 to 64 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          93
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          168
      title
      65 to 84 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          13
      title
      ≥85 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          46
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          80
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          87
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          140
        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
          6
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          6
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          125
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          125
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          87
        3. group Id
          BG002
          value
          89
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. 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
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        title
        Asian
      3. 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 Islander
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          121
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          121
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          87
        3. group Id
          BG002
          value
          92
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
The Safety Analysis Set included all participants who received any amount of study treatment.

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

Preserved source evidence · Not medical advice