Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01915498 · BASELINE

Baseline characteristics

Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation · Source last updated 2024-10-22

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
      7
    2. group Id
      BG001
      value
      7
    3. group Id
      BG002
      value
      7
    4. group Id
      BG003
      value
      8
    5. group Id
      BG004
      value
      5
    6. group Id
      BG005
      value
      9
    7. group Id
      BG006
      value
      7
    8. group Id
      BG007
      value
      22
    9. group Id
      BG008
      value
      6
    10. group Id
      BG009
      value
      14
    11. group Id
      BG010
      value
      9
    12. group Id
      BG011
      value
      5
    units
    Participants
groups
  1. description
    Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    BG000
    title
    Phase 1 Dose Escalation: Enasidenib 30 mg BID
  2. description
    Participants received enasidenib 50 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    BG001
    title
    Phase 1 Dose Escalation: Enasidenib 50 mg BID
  3. description
    Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    BG002
    title
    Phase 1 Dose Escalation: Enasidenib 75 mg BID
  4. description
    Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    BG003
    title
    Phase 1 Dose Escalation: Enasidenib 100 mg BID
  5. description
    Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    BG004
    title
    Phase 1 Dose Escalation: Enasidenib 150 mg BID
  6. description
    Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    BG005
    title
    Phase 1 Dose Escalation: Enasidenib 50 mg QD
  7. description
    Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    BG006
    title
    Phase 1 Dose Escalation: Enasidenib 75 mg QD
  8. description
    Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    BG007
    title
    Phase 1 Dose Escalation: Enasidenib 100 mg QD
  9. description
    Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    BG008
    title
    Phase 1 Dose Escalation: Enasidenib 150 mg QD
  10. description
    Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    BG009
    title
    Phase 1 Dose Escalation: Enasidenib 200 mg QD
  11. description
    Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    BG010
    title
    Phase 1 Dose Escalation: Enasidenib 300 mg QD
  12. description
    Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    BG011
    title
    Phase 1 Dose Escalation: Enasidenib 450 mg QD
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.37
          value
          62.6
        2. group Id
          BG001
          spread
          8.86
          value
          61.3
        3. group Id
          BG002
          spread
          8.38
          value
          64.7
        4. group Id
          BG003
          spread
          12.88
          value
          67.6
        5. group Id
          BG004
          spread
          7.23
          value
          73.6
        6. group Id
          BG005
          spread
          9.00
          value
          71.8
        7. group Id
          BG006
          spread
          13.77
          value
          62.3
        8. group Id
          BG007
          spread
          15.06
          value
          63.9
        9. group Id
          BG008
          spread
          2.48
          value
          73.8
        10. group Id
          BG009
          spread
          14.69
          value
          67.5
        11. group Id
          BG010
          spread
          6.20
          value
          68.3
        12. group Id
          BG011
          spread
          8.77
          value
          70.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          5
        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
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          1
        title
        < 65 Years Old
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          5
        12. group Id
          BG011
          value
          3
        title
        ≥ 65- < 75 Years Old
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          1
        title
        ≥ 75 Years Old
      denoms
      1. counts
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          5
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          11
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          1
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          11
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          11
        11. group Id
          BG010
          value
          8
        12. group Id
          BG011
          value
          4
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          5
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    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
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          15
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          8
        11. group Id
          BG010
          value
          8
        12. group Id
          BG011
          value
          4
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          1
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          5
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          18
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          11
        11. group Id
          BG010
          value
          8
        12. group Id
          BG011
          value
          4
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Black
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        American Indian/Alaskan Native
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          1
        title
        Not Provided
      denoms
      1. counts
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          5
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          3
        title
        0 - Fully active
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          11
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          9
        11. group Id
          BG010
          value
          4
        12. group Id
          BG011
          value
          1
        title
        1 - Restricted but ambulatory
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          1
        title
        2 - Ambulatory but unable to work
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        3 - Limited self-care
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        4 - Completely Disabled
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          5
        units
        Participants
    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 = 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
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          19
        9. group Id
          BG008
          value
          5
        10. group Id
          BG009
          value
          10
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          1
        title
        R140
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          4
        title
        R172
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Unknown
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          5
        units
        Participants
    description
    Isocitrate dehydrogenase 2 (IDH2) gene mutations have been described in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Mutations in IDH2 most commonly lead to alterations affecting arginine-172 (R172) or arginine-140 (R140) in IDH2.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Isocitrate dehydrogenase 2 (IDH2) Mutation Type
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Heterozygous
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          0
        title
        Homozygous
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Wild Type
      4. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          21
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          8
        12. group Id
          BG011
          value
          5
        title
        Not Applicable
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          5
        units
        Participants
    description
    The UGT1A1 gene produces a protein, called the bilirubin uridine diphosphate glucuronosyl transferase (bilirubin-UGT) enzyme, an enzyme that glucuronidates bilirubin, a substance produced when red blood cells are broken down. This enzyme converts the toxic form of bilirubin (unconjugated bilirubin) to its nontoxic form (conjugated bilirubin), making it able to be dissolved and removed from the body. Enasidenib is an inhibitor of UGT1A1. Screening for UGT1A1 mutation was added in Protocol Amendment 4 therefore data are not not available for participants enrolled prior to Amendment 4.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Uridine Diphosphate-Glucuronosyltransferase 1 Family, Polypeptide A1 (UGT1A1) Mutation Status
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Favorable-Risk
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          9
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          3
        title
        Intermediate-Risk
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        title
        Poor-Risk
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Failure
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          1
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          5
        units
        Participants
    description
    Cytogenetic risk classification according to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Acute Myeloid Leukemia. Risk categories are based on analysis of cytogenetics (the study of chromosomes), including chromosomal deletions, duplications, or substitutions and analysis of molecular abnormalities such as specific mutations. Better risk indicates disease more likely to respond to initial treatment and less likely to relapse whereas poor-risk is characterized by poor response to induction chemotherapy and higher relapse rates.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cytogenetic Risk Status
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          0
        title
        < 20% Blasts
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          0
        title
        20% to < 30% Blasts
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          2
        title
        30% to < 50% Blasts
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          11
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          3
        title
        ≥ 50% Blasts
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          5
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Bone Marrow Blasts
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          19
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          9
        11. group Id
          BG010
          value
          8
        12. group Id
          BG011
          value
          3
        title
        Relapsed / Refractory Acute Myeloid Leukemia (AML)
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          2
        title
        Untreated AML
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          0
        title
        Myelodysplastic Syndrome (MDS)
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Other
      denoms
      1. counts
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          5
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Malignancy Type
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          72.0
          upper Limit
          95.0
          value
          82.0
        2. group Id
          BG001
          lower Limit
          82.0
          upper Limit
          138.0
          value
          97.0
        3. group Id
          BG002
          lower Limit
          76.0
          upper Limit
          111.0
          value
          86.0
        4. group Id
          BG003
          lower Limit
          75.0
          upper Limit
          109.0
          value
          97.5
        5. group Id
          BG004
          lower Limit
          75.0
          upper Limit
          93.0
          value
          91.0
        6. group Id
          BG005
          lower Limit
          77.0
          upper Limit
          102.0
          value
          89.0
        7. group Id
          BG006
          lower Limit
          73.0
          upper Limit
          110.0
          value
          92.0
        8. group Id
          BG007
          lower Limit
          78.0
          upper Limit
          124.0
          value
          96.5
        9. group Id
          BG008
          lower Limit
          79.0
          upper Limit
          132.0
          value
          94.0
        10. group Id
          BG009
          lower Limit
          76.0
          upper Limit
          125.0
          value
          87.5
        11. group Id
          BG010
          lower Limit
          78.0
          upper Limit
          131.0
          value
          93.0
        12. group Id
          BG011
          lower Limit
          70.0
          upper Limit
          121.0
          value
          103.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          5
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Participants with available data.
    title
    Hemoglobin
    unit Of Measure
    g/L
population Description
The full analysis set includes all participants who received at least one dose of study treatment.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      7
    2. group Id
      BG001
      value
      7
    3. group Id
      BG002
      value
      7
    4. group Id
      BG003
      value
      8
    5. group Id
      BG004
      value
      5
    6. group Id
      BG005
      value
      9
    7. group Id
      BG006
      value
      7
    8. group Id
      BG007
      value
      22
    9. group Id
      BG008
      value
      6
    10. group Id
      BG009
      value
      14
    11. group Id
      BG010
      value
      9
    12. group Id
      BG011
      value
      5
    units
    Participants
groups
  1. description
    Participants received enasidenib 30 mg tablets twice a day (BID) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    BG000
    title
    Phase 1 Dose Escalation: Enasidenib 30 mg BID
  2. description
    Participants received enasidenib 50 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    BG001
    title
    Phase 1 Dose Escalation: Enasidenib 50 mg BID
  3. description
    Participants received enasidenib 75 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    BG002
    title
    Phase 1 Dose Escalation: Enasidenib 75 mg BID
  4. description
    Participants received enasidenib 100 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    BG003
    title
    Phase 1 Dose Escalation: Enasidenib 100 mg BID
  5. description
    Participants received enasidenib 150 mg tablets BID on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    BG004
    title
    Phase 1 Dose Escalation: Enasidenib 150 mg BID
  6. description
    Participants received enasidenib 50 mg tablets once a day (QD) on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    BG005
    title
    Phase 1 Dose Escalation: Enasidenib 50 mg QD
  7. description
    Participants received enasidenib 75 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    BG006
    title
    Phase 1 Dose Escalation: Enasidenib 75 mg QD
  8. description
    Participants received enasidenib 100 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    BG007
    title
    Phase 1 Dose Escalation: Enasidenib 100 mg QD
  9. description
    Participants received enasidenib 150 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    BG008
    title
    Phase 1 Dose Escalation: Enasidenib 150 mg QD
  10. description
    Participants received enasidenib 200 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    BG009
    title
    Phase 1 Dose Escalation: Enasidenib 200 mg QD
  11. description
    Participants received enasidenib 300 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    BG010
    title
    Phase 1 Dose Escalation: Enasidenib 300 mg QD
  12. description
    Participants received enasidenib 450 mg tablets QD on Day 1 to Day 28 of each 28-day treatment cycle until disease progression or development of unacceptable toxicity.
    id
    BG011
    title
    Phase 1 Dose Escalation: Enasidenib 450 mg QD
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.37
          value
          62.6
        2. group Id
          BG001
          spread
          8.86
          value
          61.3
        3. group Id
          BG002
          spread
          8.38
          value
          64.7
        4. group Id
          BG003
          spread
          12.88
          value
          67.6
        5. group Id
          BG004
          spread
          7.23
          value
          73.6
        6. group Id
          BG005
          spread
          9.00
          value
          71.8
        7. group Id
          BG006
          spread
          13.77
          value
          62.3
        8. group Id
          BG007
          spread
          15.06
          value
          63.9
        9. group Id
          BG008
          spread
          2.48
          value
          73.8
        10. group Id
          BG009
          spread
          14.69
          value
          67.5
        11. group Id
          BG010
          spread
          6.20
          value
          68.3
        12. group Id
          BG011
          spread
          8.77
          value
          70.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          5
        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
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          10
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          1
        title
        < 65 Years Old
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          5
        12. group Id
          BG011
          value
          3
        title
        ≥ 65- < 75 Years Old
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          1
        title
        ≥ 75 Years Old
      denoms
      1. counts
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          5
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          11
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          1
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          11
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          11
        11. group Id
          BG010
          value
          8
        12. group Id
          BG011
          value
          4
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          5
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    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
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          15
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          8
        11. group Id
          BG010
          value
          8
        12. group Id
          BG011
          value
          4
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          6
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          1
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          5
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          18
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          11
        11. group Id
          BG010
          value
          8
        12. group Id
          BG011
          value
          4
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Black
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        American Indian/Alaskan Native
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          1
        title
        Not Provided
      denoms
      1. counts
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          5
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          3
        title
        0 - Fully active
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          11
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          9
        11. group Id
          BG010
          value
          4
        12. group Id
          BG011
          value
          1
        title
        1 - Restricted but ambulatory
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          1
        title
        2 - Ambulatory but unable to work
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        3 - Limited self-care
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        4 - Completely Disabled
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          5
        units
        Participants
    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 = 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
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          19
        9. group Id
          BG008
          value
          5
        10. group Id
          BG009
          value
          10
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          1
        title
        R140
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          4
        title
        R172
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Unknown
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          5
        units
        Participants
    description
    Isocitrate dehydrogenase 2 (IDH2) gene mutations have been described in patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Mutations in IDH2 most commonly lead to alterations affecting arginine-172 (R172) or arginine-140 (R140) in IDH2.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Isocitrate dehydrogenase 2 (IDH2) Mutation Type
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Heterozygous
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          0
        title
        Homozygous
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Wild Type
      4. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          21
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          8
        12. group Id
          BG011
          value
          5
        title
        Not Applicable
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          5
        units
        Participants
    description
    The UGT1A1 gene produces a protein, called the bilirubin uridine diphosphate glucuronosyl transferase (bilirubin-UGT) enzyme, an enzyme that glucuronidates bilirubin, a substance produced when red blood cells are broken down. This enzyme converts the toxic form of bilirubin (unconjugated bilirubin) to its nontoxic form (conjugated bilirubin), making it able to be dissolved and removed from the body. Enasidenib is an inhibitor of UGT1A1. Screening for UGT1A1 mutation was added in Protocol Amendment 4 therefore data are not not available for participants enrolled prior to Amendment 4.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Uridine Diphosphate-Glucuronosyltransferase 1 Family, Polypeptide A1 (UGT1A1) Mutation Status
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Favorable-Risk
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          9
        11. group Id
          BG010
          value
          6
        12. group Id
          BG011
          value
          3
        title
        Intermediate-Risk
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          1
        title
        Poor-Risk
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Failure
      5. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          1
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          5
        units
        Participants
    description
    Cytogenetic risk classification according to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Acute Myeloid Leukemia. Risk categories are based on analysis of cytogenetics (the study of chromosomes), including chromosomal deletions, duplications, or substitutions and analysis of molecular abnormalities such as specific mutations. Better risk indicates disease more likely to respond to initial treatment and less likely to relapse whereas poor-risk is characterized by poor response to induction chemotherapy and higher relapse rates.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cytogenetic Risk Status
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          0
        title
        < 20% Blasts
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          0
        title
        20% to < 30% Blasts
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          5
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          2
        12. group Id
          BG011
          value
          2
        title
        30% to < 50% Blasts
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          11
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          3
        title
        ≥ 50% Blasts
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          5
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Bone Marrow Blasts
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          19
        9. group Id
          BG008
          value
          3
        10. group Id
          BG009
          value
          9
        11. group Id
          BG010
          value
          8
        12. group Id
          BG011
          value
          3
        title
        Relapsed / Refractory Acute Myeloid Leukemia (AML)
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          2
        title
        Untreated AML
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          0
        title
        Myelodysplastic Syndrome (MDS)
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          0
        title
        Other
      denoms
      1. counts
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          5
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Malignancy Type
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          72.0
          upper Limit
          95.0
          value
          82.0
        2. group Id
          BG001
          lower Limit
          82.0
          upper Limit
          138.0
          value
          97.0
        3. group Id
          BG002
          lower Limit
          76.0
          upper Limit
          111.0
          value
          86.0
        4. group Id
          BG003
          lower Limit
          75.0
          upper Limit
          109.0
          value
          97.5
        5. group Id
          BG004
          lower Limit
          75.0
          upper Limit
          93.0
          value
          91.0
        6. group Id
          BG005
          lower Limit
          77.0
          upper Limit
          102.0
          value
          89.0
        7. group Id
          BG006
          lower Limit
          73.0
          upper Limit
          110.0
          value
          92.0
        8. group Id
          BG007
          lower Limit
          78.0
          upper Limit
          124.0
          value
          96.5
        9. group Id
          BG008
          lower Limit
          79.0
          upper Limit
          132.0
          value
          94.0
        10. group Id
          BG009
          lower Limit
          76.0
          upper Limit
          125.0
          value
          87.5
        11. group Id
          BG010
          lower Limit
          78.0
          upper Limit
          131.0
          value
          93.0
        12. group Id
          BG011
          lower Limit
          70.0
          upper Limit
          121.0
          value
          103.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          9
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          22
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          14
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          5
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Participants with available data.
    title
    Hemoglobin
    unit Of Measure
    g/L
population Description
The full analysis set includes all participants who received at least one dose of study treatment.

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

Preserved source evidence · Not medical advice