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NCT01587703 · BASELINE

Baseline characteristics

A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of GSK525762 in Subjects With NUT Midline Carcinoma (NMC) and Other Cancers · Source last updated 2020-03-16

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
      4
    2. group Id
      BG001
      value
      1
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      4
    5. group Id
      BG004
      value
      9
    6. group Id
      BG005
      value
      32
    7. group Id
      BG006
      value
      9
    8. group Id
      BG007
      value
      4
    9. group Id
      BG008
      value
      10
    10. group Id
      BG009
      value
      5
    11. group Id
      BG010
      value
      10
    12. group Id
      BG011
      value
      12
    units
    Participants
groups
  1. description
    Participants were administered once daily oral dose of 4 mg GSK525762
    id
    BG000
    title
    Part 1: GSK525762 4 mg QD
  2. description
    Participants were administered once daily oral dose of 8 mg GSK525762.
    id
    BG001
    title
    Part 1: GSK525762 8 mg QD
  3. description
    Participants were administered once daily oral dose of 16 mg GSK525762.
    id
    BG002
    title
    Part 1: GSK525762 16 mg QD
  4. description
    Participants were administered once daily oral dose of 30 mg GSK525762.
    id
    BG003
    title
    Part 1: GSK525762 30 mg QD
  5. description
    Participants were administered once daily oral dose of 60 mg GSK525762.
    id
    BG004
    title
    Part 1: GSK525762 60 mg QD
  6. description
    Participants were administered once daily oral dose of 80 mg GSK525762.
    id
    BG005
    title
    Part 1: GSK525762 80 mg QD
  7. description
    Participants were administered once daily oral dose of 100 mg GSK525762.
    id
    BG006
    title
    Part 1: GSK525762 100 mg QD
  8. description
    Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
    id
    BG007
    title
    Part 1: GSK525762 20 mg BID
  9. description
    Participants were administered twice daily oral dose of 30 mg GSK525762.
    id
    BG008
    title
    Part 1: GSK525762 30 mg BID
  10. description
    Participants were administered twice daily oral dose of 40 mg GSK525762.
    id
    BG009
    title
    Part 1: GSK525762 40 mg BID
  11. description
    All participants who entered besylate sub-study and received 80 mg amor free-base tablet along with 6 mg stable iso in solution in fasted state; 80 mg bes tablet along with 6 mg stable iso in solution in fasted state, 30 mg bes tablet along with 6 mg stable iso in solution in fasted state and 80 mg bes tablet with FDA recommended high fat breakfast in one of the treatment periods were included.
    id
    BG010
    title
    All Participants in Besylate Substudy
  12. description
    Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762.
    id
    BG011
    title
    Part 2: Participants With NMC
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          19.44
          value
          47.0
        2. comment
          Standard deviation could not be calculated as only one participant was analyzed
          group Id
          BG001
          spread
          NA
          value
          39.0
        3. group Id
          BG002
          spread
          4.19
          value
          53.7
        4. group Id
          BG003
          spread
          23.27
          value
          49.3
        5. group Id
          BG004
          spread
          17.06
          value
          46.7
        6. group Id
          BG005
          spread
          16.82
          value
          51.5
        7. group Id
          BG006
          spread
          19.92
          value
          58.3
        8. group Id
          BG007
          spread
          6.45
          value
          66.5
        9. group Id
          BG008
          spread
          8.42
          value
          63.5
        10. group Id
          BG009
          spread
          4.83
          value
          60.4
        11. group Id
          BG010
          spread
          9.96
          value
          55.2
        12. group Id
          BG011
          spread
          18.05
          value
          42.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          14
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          5
        12. group Id
          BG011
          value
          7
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          18
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          5
        12. group Id
          BG011
          value
          5
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        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 or Alaska Native
      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
          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
          1
        title
        Central/South Asian Heritage (Her)
      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
          0
        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
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          2
        title
        Japanese Her/East Asian Her/South East Asian Her
      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
          1
        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
          0
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          30
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          10
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          6
        title
        White
      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
          3
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      4
    2. group Id
      BG001
      value
      1
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      4
    5. group Id
      BG004
      value
      9
    6. group Id
      BG005
      value
      32
    7. group Id
      BG006
      value
      9
    8. group Id
      BG007
      value
      4
    9. group Id
      BG008
      value
      10
    10. group Id
      BG009
      value
      5
    11. group Id
      BG010
      value
      10
    12. group Id
      BG011
      value
      12
    units
    Participants
groups
  1. description
    Participants were administered once daily oral dose of 4 mg GSK525762
    id
    BG000
    title
    Part 1: GSK525762 4 mg QD
  2. description
    Participants were administered once daily oral dose of 8 mg GSK525762.
    id
    BG001
    title
    Part 1: GSK525762 8 mg QD
  3. description
    Participants were administered once daily oral dose of 16 mg GSK525762.
    id
    BG002
    title
    Part 1: GSK525762 16 mg QD
  4. description
    Participants were administered once daily oral dose of 30 mg GSK525762.
    id
    BG003
    title
    Part 1: GSK525762 30 mg QD
  5. description
    Participants were administered once daily oral dose of 60 mg GSK525762.
    id
    BG004
    title
    Part 1: GSK525762 60 mg QD
  6. description
    Participants were administered once daily oral dose of 80 mg GSK525762.
    id
    BG005
    title
    Part 1: GSK525762 80 mg QD
  7. description
    Participants were administered once daily oral dose of 100 mg GSK525762.
    id
    BG006
    title
    Part 1: GSK525762 100 mg QD
  8. description
    Participants were administered twice daily (BID) oral dose of 20 mg GSK525762.
    id
    BG007
    title
    Part 1: GSK525762 20 mg BID
  9. description
    Participants were administered twice daily oral dose of 30 mg GSK525762.
    id
    BG008
    title
    Part 1: GSK525762 30 mg BID
  10. description
    Participants were administered twice daily oral dose of 40 mg GSK525762.
    id
    BG009
    title
    Part 1: GSK525762 40 mg BID
  11. description
    All participants who entered besylate sub-study and received 80 mg amor free-base tablet along with 6 mg stable iso in solution in fasted state; 80 mg bes tablet along with 6 mg stable iso in solution in fasted state, 30 mg bes tablet along with 6 mg stable iso in solution in fasted state and 80 mg bes tablet with FDA recommended high fat breakfast in one of the treatment periods were included.
    id
    BG010
    title
    All Participants in Besylate Substudy
  12. description
    Participants with NUT Midline Carcinoma (NMC) were administered continuous once daily oral dose of 75 mg GSK525762.
    id
    BG011
    title
    Part 2: Participants With NMC
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          19.44
          value
          47.0
        2. comment
          Standard deviation could not be calculated as only one participant was analyzed
          group Id
          BG001
          spread
          NA
          value
          39.0
        3. group Id
          BG002
          spread
          4.19
          value
          53.7
        4. group Id
          BG003
          spread
          23.27
          value
          49.3
        5. group Id
          BG004
          spread
          17.06
          value
          46.7
        6. group Id
          BG005
          spread
          16.82
          value
          51.5
        7. group Id
          BG006
          spread
          19.92
          value
          58.3
        8. group Id
          BG007
          spread
          6.45
          value
          66.5
        9. group Id
          BG008
          spread
          8.42
          value
          63.5
        10. group Id
          BG009
          spread
          4.83
          value
          60.4
        11. group Id
          BG010
          spread
          9.96
          value
          55.2
        12. group Id
          BG011
          spread
          18.05
          value
          42.9
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          14
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          5
        12. group Id
          BG011
          value
          7
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          18
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          2
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          4
        11. group Id
          BG010
          value
          5
        12. group Id
          BG011
          value
          5
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        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 or Alaska Native
      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
          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
          1
        title
        Central/South Asian Heritage (Her)
      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
          0
        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
          0
        10. group Id
          BG009
          value
          0
        11. group Id
          BG010
          value
          0
        12. group Id
          BG011
          value
          2
        title
        Japanese Her/East Asian Her/South East Asian Her
      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
          1
        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
          0
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          30
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          10
        10. group Id
          BG009
          value
          5
        11. group Id
          BG010
          value
          9
        12. group Id
          BG011
          value
          6
        title
        White
      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
          3
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice