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NCT02989857 · BASELINE

Baseline characteristics

Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy) · Source last updated 2024-08-20

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
      126
    2. group Id
      BG001
      value
      61
    3. group Id
      BG002
      value
      187
    units
    Participants
groups
  1. description
    Participants received AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study for up to approximately 45 months.
    id
    BG000
    title
    AG-120
  2. description
    Participants received AG-120 matched placebo, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up or the sponsor ended the study for up to approximately 7 months. Participants who experienced disease progression and received placebo were allowed to cross over and receive AG-120.
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.97
          value
          60.3
        2. group Id
          BG001
          spread
          10.38
          value
          62.9
        3. group Id
          BG002
          spread
          10.82
          value
          61.1
    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
          82
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          119
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          68
        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
          7
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          124
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Not Reported
      4. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          52
        title
        Missing
      title
      Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          23
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      5. measurements
        1. group Id
          BG000
          value
          71
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          106
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Not Reported
      8. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          52
        title
        Missing
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Intent-To-Treat (ITT) Set included all participants who were randomized, with the treatment group designated according to the randomization.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      126
    2. group Id
      BG001
      value
      61
    3. group Id
      BG002
      value
      187
    units
    Participants
groups
  1. description
    Participants received AG-120 500 mg, tablet, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up, or the sponsor ended the study for up to approximately 45 months.
    id
    BG000
    title
    AG-120
  2. description
    Participants received AG-120 matched placebo, orally, QD in each 28-day treatment cycle, until occurrence of disease progression, unacceptable toxicity, confirmed pregnancy, death, subject withdrawal, lost to follow-up or the sponsor ended the study for up to approximately 7 months. Participants who experienced disease progression and received placebo were allowed to cross over and receive AG-120.
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.97
          value
          60.3
        2. group Id
          BG001
          spread
          10.38
          value
          62.9
        3. group Id
          BG002
          spread
          10.82
          value
          61.1
    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
          82
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          119
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          68
        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
          7
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          84
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          124
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Not Reported
      4. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          52
        title
        Missing
      title
      Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          23
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      5. measurements
        1. group Id
          BG000
          value
          71
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          106
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Not Reported
      8. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          52
        title
        Missing
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Intent-To-Treat (ITT) Set included all participants who were randomized, with the treatment group designated according to the randomization.

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

Preserved source evidence · Not medical advice