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NCT02393248 · BASELINE

Baseline characteristics

Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101) · Source last updated 2023-01-06

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
      4
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      9
    7. group Id
      BG006
      value
      10
    8. group Id
      BG007
      value
      9
    9. group Id
      BG008
      value
      4
    10. group Id
      BG009
      value
      3
    11. group Id
      BG010
      value
      4
    12. group Id
      BG011
      value
      44
    units
    Participants
groups
  1. description
    Participants self-administered oral pemigatinib 1/2/4 milligrams (mg) once daily (QD) on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
    id
    BG000
    title
    Part 1: Intermittent Pemigatinib 1/2/4 mg QD
  2. description
    Participants self-administered oral pemigatinib 6 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
    id
    BG001
    title
    Part 1: Intermittent Pemigatinib 6 mg QD
  3. description
    Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
    id
    BG002
    title
    Part 1: Intermittent Pemigatinib 9 mg QD
  4. description
    Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
    id
    BG003
    title
    Part 1: Intermittent Pemigatinib 13.5 mg QD
  5. description
    Participants self-administered oral pemigatinib 20 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
    id
    BG004
    title
    Part 1: Intermittent Pemigatinib 20 mg QD
  6. description
    Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.
    id
    BG005
    title
    Part 1: Continuous Pemigatinib 9 mg QD
  7. description
    Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.
    id
    BG006
    title
    Part 1: Continuous Pemigatinib 13.5 mg QD
  8. description
    Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.
    id
    BG007
    title
    Part 1: Continuous Pemigatinib 20 mg QD
  9. description
    Participants self-administered oral pemigatinib 7.5 mg twice daily (BID) on Days 1 through 21 of each 21-day cycle.
    id
    BG008
    title
    Part 1: Continuous Pemigatinib 7.5 mg BID
  10. description
    Participants self-administered oral pemigatinib 10 mg BID on Days 1 through 21 of each 21-day cycle.
    id
    BG009
    title
    Part 1: Continuous Pemigatinib 10 mg BID
  11. description
    Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
    id
    BG010
    title
    Part 2: Intermittent Pemigatinib 9 mg QD
  12. description
    Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
    id
    BG011
    title
    Part 2: Intermittent Pemigatinib 13.5 mg QD
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.24
          value
          60.7
        2. group Id
          BG001
          spread
          17.31
          value
          45.5
        3. group Id
          BG002
          spread
          4.93
          value
          56.3
        4. group Id
          BG003
          spread
          14.79
          value
          59.0
        5. group Id
          BG004
          spread
          11.89
          value
          56.2
        6. group Id
          BG005
          spread
          15.70
          value
          57.9
        7. group Id
          BG006
          spread
          16.88
          value
          61.2
        8. group Id
          BG007
          spread
          15.19
          value
          56.3
        9. group Id
          BG008
          spread
          4.57
          value
          66.8
        10. group Id
          BG009
          spread
          15.89
          value
          68.7
        11. group Id
          BG010
          spread
          12.39
          value
          50.3
        12. group Id
          BG011
          spread
          11.81
          value
          57.7
    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
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          27
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          17
        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
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        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
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          9
        8. group Id
          BG007
          value
          9
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          39
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        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
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          37
      title
      White/Caucasian
    2. 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
          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
          7
      title
      Black/African-American
    3. 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
          1
        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
          0
      title
      Asian
    4. 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
      American-Indian/Alaska Native
    5. 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
      Native Hawaiian/Pacific Islander
    6. 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
          1
        12. group Id
          BG011
          value
          0
      title
      Captured as Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      4
    3. group Id
      BG002
      value
      3
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      6
    6. group Id
      BG005
      value
      9
    7. group Id
      BG006
      value
      10
    8. group Id
      BG007
      value
      9
    9. group Id
      BG008
      value
      4
    10. group Id
      BG009
      value
      3
    11. group Id
      BG010
      value
      4
    12. group Id
      BG011
      value
      44
    units
    Participants
groups
  1. description
    Participants self-administered oral pemigatinib 1/2/4 milligrams (mg) once daily (QD) on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
    id
    BG000
    title
    Part 1: Intermittent Pemigatinib 1/2/4 mg QD
  2. description
    Participants self-administered oral pemigatinib 6 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
    id
    BG001
    title
    Part 1: Intermittent Pemigatinib 6 mg QD
  3. description
    Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
    id
    BG002
    title
    Part 1: Intermittent Pemigatinib 9 mg QD
  4. description
    Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
    id
    BG003
    title
    Part 1: Intermittent Pemigatinib 13.5 mg QD
  5. description
    Participants self-administered oral pemigatinib 20 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
    id
    BG004
    title
    Part 1: Intermittent Pemigatinib 20 mg QD
  6. description
    Participants self-administered oral pemigatinib 9 mg QD on Days 1 through 21 of each 21-day cycle.
    id
    BG005
    title
    Part 1: Continuous Pemigatinib 9 mg QD
  7. description
    Participants self-administered oral pemigatinib 13.5 mg QD on Days 1 through 21 of each 21-day cycle.
    id
    BG006
    title
    Part 1: Continuous Pemigatinib 13.5 mg QD
  8. description
    Participants self-administered oral pemigatinib 20 mg QD on Days 1 through 21 of each 21-day cycle.
    id
    BG007
    title
    Part 1: Continuous Pemigatinib 20 mg QD
  9. description
    Participants self-administered oral pemigatinib 7.5 mg twice daily (BID) on Days 1 through 21 of each 21-day cycle.
    id
    BG008
    title
    Part 1: Continuous Pemigatinib 7.5 mg BID
  10. description
    Participants self-administered oral pemigatinib 10 mg BID on Days 1 through 21 of each 21-day cycle.
    id
    BG009
    title
    Part 1: Continuous Pemigatinib 10 mg BID
  11. description
    Participants self-administered oral pemigatinib 9 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
    id
    BG010
    title
    Part 2: Intermittent Pemigatinib 9 mg QD
  12. description
    Participants self-administered oral pemigatinib 13.5 mg QD on a 2-weeks-on therapy and 1-week-off therapy schedule. The treatment cycle consisted of: Days 1 through 14: pemigatinib QD; Days 15 through 21: treatment break.
    id
    BG011
    title
    Part 2: Intermittent Pemigatinib 13.5 mg QD
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.24
          value
          60.7
        2. group Id
          BG001
          spread
          17.31
          value
          45.5
        3. group Id
          BG002
          spread
          4.93
          value
          56.3
        4. group Id
          BG003
          spread
          14.79
          value
          59.0
        5. group Id
          BG004
          spread
          11.89
          value
          56.2
        6. group Id
          BG005
          spread
          15.70
          value
          57.9
        7. group Id
          BG006
          spread
          16.88
          value
          61.2
        8. group Id
          BG007
          spread
          15.19
          value
          56.3
        9. group Id
          BG008
          spread
          4.57
          value
          66.8
        10. group Id
          BG009
          spread
          15.89
          value
          68.7
        11. group Id
          BG010
          spread
          12.39
          value
          50.3
        12. group Id
          BG011
          spread
          11.81
          value
          57.7
    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
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          6
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          27
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          3
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          1
        11. group Id
          BG010
          value
          1
        12. group Id
          BG011
          value
          17
        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
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          1
        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
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          9
        8. group Id
          BG007
          value
          9
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          39
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        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
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          8
        7. group Id
          BG006
          value
          10
        8. group Id
          BG007
          value
          8
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          3
        11. group Id
          BG010
          value
          3
        12. group Id
          BG011
          value
          37
      title
      White/Caucasian
    2. 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
          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
          7
      title
      Black/African-American
    3. 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
          1
        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
          0
      title
      Asian
    4. 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
      American-Indian/Alaska Native
    5. 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
      Native Hawaiian/Pacific Islander
    6. 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
          1
        12. group Id
          BG011
          value
          0
      title
      Captured as Other
    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