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NCT02924376 · BASELINE

Baseline characteristics

Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy - (FIGHT-202) · Source last updated 2025-08-14

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
      108
    2. group Id
      BG001
      value
      20
    3. group Id
      BG002
      value
      17
    4. group Id
      BG003
      value
      2
    5. group Id
      BG004
      value
      147
    units
    Participants
groups
  1. description
    Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
    id
    BG000
    title
    Cohort A: FGFR2 Rearrangements or Fusions
  2. description
    Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
    id
    BG001
    title
    Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
  3. description
    Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.
    id
    BG002
    title
    Cohort C: Negative for FGF/FGFR Alterations
  4. description
    Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
    id
    BG003
    title
    Other
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.00
          value
          55.2
        2. group Id
          BG001
          spread
          10.99
          value
          61.9
        3. group Id
          BG002
          spread
          7.12
          value
          65.6
        4. group Id
          BG003
          spread
          14.14
          value
          41.0
        5. group Id
          BG004
          spread
          12.08
          value
          57.1
    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
          66
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          85
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          62
        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
          79
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          104
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          8
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          23
      title
      Asian
    4. 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
      title
      American-Indian/Alaska Native
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          5
      title
      Captured as "Other"
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          6
      title
      Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          6
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          88
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          121
      title
      Not Hispanic or Latino
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          15
      title
      Not Reported
    4. categories
      1. 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
          1
      title
      Unknown
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
      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
      108
    2. group Id
      BG001
      value
      20
    3. group Id
      BG002
      value
      17
    4. group Id
      BG003
      value
      2
    5. group Id
      BG004
      value
      147
    units
    Participants
groups
  1. description
    Participants with fibroblast growth factor (FGF) receptor 2 (FGFR2) rearrangements or fusions self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
    id
    BG000
    title
    Cohort A: FGFR2 Rearrangements or Fusions
  2. description
    Participants with all other FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
    id
    BG001
    title
    Cohort B: FGF/FGFR Alterations Other Than FGFR2 Rearrangements or Fusions
  3. description
    Participants with no FGF/FGFR alterations self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles (United States only). Pemigatinib was administered until documented disease progression or unacceptable toxicity.
    id
    BG002
    title
    Cohort C: Negative for FGF/FGFR Alterations
  4. description
    Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD on a 2-weeks-on therapy/1-week-off schedule in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.
    id
    BG003
    title
    Other
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          12.00
          value
          55.2
        2. group Id
          BG001
          spread
          10.99
          value
          61.9
        3. group Id
          BG002
          spread
          7.12
          value
          65.6
        4. group Id
          BG003
          spread
          14.14
          value
          41.0
        5. group Id
          BG004
          spread
          12.08
          value
          57.1
    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
          66
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          85
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          62
        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
          79
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          104
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          8
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          23
      title
      Asian
    4. 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
      title
      American-Indian/Alaska Native
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          5
      title
      Captured as "Other"
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          6
      title
      Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          6
      title
      Hispanic or Latino
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          88
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          121
      title
      Not Hispanic or Latino
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          15
      title
      Not Reported
    4. categories
      1. 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
          1
      title
      Unknown
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          4
      title
      Captured as "Other"
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice