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NCT01713582 · BASELINE

Baseline characteristics

A Dose-finding Study of the Bromodomain (Brd) Inhibitor OTX015/ Birabresib (MK-8628) in Hematologic Malignancies (MK-8628-001) · Source last updated 2021-01-26

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
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      4
    4. group Id
      BG003
      value
      3
    5. group Id
      BG004
      value
      4
    6. group Id
      BG005
      value
      8
    7. group Id
      BG006
      value
      7
    8. group Id
      BG007
      value
      6
    9. group Id
      BG008
      value
      6
    10. group Id
      BG009
      value
      18
    11. group Id
      BG010
      value
      16
    12. group Id
      BG011
      value
      5
    units
    Participants
groups
  1. description
    Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    BG000
    title
    AL 10 mg QD 14-21
  2. description
    Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    BG001
    title
    AL 20 mg QD 14-21
  3. description
    Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    BG002
    title
    AL 40 mg QD 14-21
  4. description
    Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
    id
    BG003
    title
    AL 20 mg BID 21-21
  5. description
    Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    BG004
    title
    AL 80 mg QD 14-21
  6. description
    Participants received 40 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
    id
    BG005
    title
    AL 40 mg BID 14-21
  7. description
    Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    BG006
    title
    AL 120 mg QD 14-21
  8. description
    Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
    id
    BG007
    title
    AL 120 mg QD 21-21
  9. description
    Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    BG008
    title
    AL 160 mg QD 14-21
  10. description
    Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    BG009
    title
    AML de Novo 80 mg QD 14-21
  11. description
    Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    BG010
    title
    AML/MDS 80 mg QD 14-21
  12. description
    Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
    id
    BG011
    title
    OHM 10 mg QD 21-21
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          65.0
          spread
          3.5
          upper Limit
          71.0
          value
          67.0
        2. group Id
          BG001
          lower Limit
          32.0
          spread
          19.6
          upper Limit
          66.0
          value
          54.7
        3. group Id
          BG002
          lower Limit
          71.0
          spread
          2.1
          upper Limit
          76.0
          value
          73.8
        4. group Id
          BG003
          lower Limit
          75.0
          spread
          2.3
          upper Limit
          79.0
          value
          77.7
        5. group Id
          BG004
          lower Limit
          55.0
          spread
          10.6
          upper Limit
          80.0
          value
          70.0
        6. group Id
          BG005
          lower Limit
          33.0
          spread
          16.3
          upper Limit
          85.0
          value
          65.8
        7. group Id
          BG006
          lower Limit
          42.0
          spread
          13.9
          upper Limit
          79.0
          value
          65.3
        8. group Id
          BG007
          lower Limit
          19.0
          spread
          24.1
          upper Limit
          80.0
          value
          58.5
        9. group Id
          BG008
          lower Limit
          26.0
          spread
          16.6
          upper Limit
          75.0
          value
          57.8
        10. group Id
          BG009
          lower Limit
          45.0
          spread
          10.0
          upper Limit
          79.0
          value
          65.6
        11. group Id
          BG010
          lower Limit
          48.0
          spread
          8.2
          upper Limit
          81.0
          value
          67.2
        12. group Id
          BG011
          spread
          15.5
          value
          65.2
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          18
        11. group Id
          BG010
          value
          16
        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
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          8
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          10
        11. group Id
          BG010
          value
          13
        12. group Id
          BG011
          value
          5
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          18
        11. group Id
          BG010
          value
          16
        12. group Id
          BG011
          value
          5
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG021
          value
          0
      denoms
      1. counts
        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
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      4
    4. group Id
      BG003
      value
      3
    5. group Id
      BG004
      value
      4
    6. group Id
      BG005
      value
      8
    7. group Id
      BG006
      value
      7
    8. group Id
      BG007
      value
      6
    9. group Id
      BG008
      value
      6
    10. group Id
      BG009
      value
      18
    11. group Id
      BG010
      value
      16
    12. group Id
      BG011
      value
      5
    units
    Participants
groups
  1. description
    Participants received 10 mg MK-8628/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    BG000
    title
    AL 10 mg QD 14-21
  2. description
    Participants received 20 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    BG001
    title
    AL 20 mg QD 14-21
  3. description
    Participants received 40 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    BG002
    title
    AL 40 mg QD 14-21
  4. description
    Participants received 20 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle.
    id
    BG003
    title
    AL 20 mg BID 21-21
  5. description
    Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    BG004
    title
    AL 80 mg QD 14-21
  6. description
    Participants received 40 mg MK-8628/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle.
    id
    BG005
    title
    AL 40 mg BID 14-21
  7. description
    Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    BG006
    title
    AL 120 mg QD 14-21
  8. description
    Participants received 120 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
    id
    BG007
    title
    AL 120 mg QD 21-21
  9. description
    Participants received 160 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    BG008
    title
    AL 160 mg QD 14-21
  10. description
    Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    BG009
    title
    AML de Novo 80 mg QD 14-21
  11. description
    Participants received 80 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle.
    id
    BG010
    title
    AML/MDS 80 mg QD 14-21
  12. description
    Participants received 10 mg MK-8628/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle.
    id
    BG011
    title
    OHM 10 mg QD 21-21
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          65.0
          spread
          3.5
          upper Limit
          71.0
          value
          67.0
        2. group Id
          BG001
          lower Limit
          32.0
          spread
          19.6
          upper Limit
          66.0
          value
          54.7
        3. group Id
          BG002
          lower Limit
          71.0
          spread
          2.1
          upper Limit
          76.0
          value
          73.8
        4. group Id
          BG003
          lower Limit
          75.0
          spread
          2.3
          upper Limit
          79.0
          value
          77.7
        5. group Id
          BG004
          lower Limit
          55.0
          spread
          10.6
          upper Limit
          80.0
          value
          70.0
        6. group Id
          BG005
          lower Limit
          33.0
          spread
          16.3
          upper Limit
          85.0
          value
          65.8
        7. group Id
          BG006
          lower Limit
          42.0
          spread
          13.9
          upper Limit
          79.0
          value
          65.3
        8. group Id
          BG007
          lower Limit
          19.0
          spread
          24.1
          upper Limit
          80.0
          value
          58.5
        9. group Id
          BG008
          lower Limit
          26.0
          spread
          16.6
          upper Limit
          75.0
          value
          57.8
        10. group Id
          BG009
          lower Limit
          45.0
          spread
          10.0
          upper Limit
          79.0
          value
          65.6
        11. group Id
          BG010
          lower Limit
          48.0
          spread
          8.2
          upper Limit
          81.0
          value
          67.2
        12. group Id
          BG011
          spread
          15.5
          value
          65.2
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          18
        11. group Id
          BG010
          value
          16
        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
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          8
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          0
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          5
        7. group Id
          BG006
          value
          4
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          10
        11. group Id
          BG010
          value
          13
        12. group Id
          BG011
          value
          5
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          18
        11. group Id
          BG010
          value
          16
        12. group Id
          BG011
          value
          5
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG021
          value
          0
      denoms
      1. counts
        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
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice