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NCT04744831 · BASELINE

Baseline characteristics

Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer · Source last updated 2026-01-14

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
      82
    2. group Id
      BG001
      value
      40
    3. group Id
      BG002
      value
      122
    units
    Participants
groups
  1. description
    Participants were randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W).
    id
    BG000
    title
    T-DXd 5.4 mg/kg Q3W
  2. description
    Participants were randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).
    id
    BG001
    title
    T-DXd 6.4 mg/kg Q3W
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          77
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          45
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The baseline demographic characteristics were assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W.
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.05
          value
          58.5
        2. group Id
          BG001
          spread
          12.13
          value
          61.1
        3. group Id
          BG002
          spread
          12.77
          value
          59.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The baseline demographic characteristics were assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W.
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          58
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          64
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The baseline demographic characteristics were assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          50
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          66
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      American Indian or Alaska Native
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      Native Hawaiian or Other Pacific Islander
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The baseline demographic characteristics were assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W.
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The baseline demographic characteristics were assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      82
    2. group Id
      BG001
      value
      40
    3. group Id
      BG002
      value
      122
    units
    Participants
groups
  1. description
    Participants were randomized to receive intravenous T-DXd administered at a dose of 5.4 mg/kg every 3 weeks (Q3W).
    id
    BG000
    title
    T-DXd 5.4 mg/kg Q3W
  2. description
    Participants were randomized to receive intravenous T-DXd administered at a dose of 6.4 mg/kg every 3 weeks (Q3W).
    id
    BG001
    title
    T-DXd 6.4 mg/kg Q3W
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          77
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          45
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The baseline demographic characteristics were assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W.
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.05
          value
          58.5
        2. group Id
          BG001
          spread
          12.13
          value
          61.1
        3. group Id
          BG002
          spread
          12.77
          value
          59.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    The baseline demographic characteristics were assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W.
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          58
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          64
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The baseline demographic characteristics were assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          50
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          66
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      American Indian or Alaska Native
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      Native Hawaiian or Other Pacific Islander
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    The baseline demographic characteristics were assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W.
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The baseline demographic characteristics were assessed in the Full Analysis Set, which included 1 participant who was randomized/registered to T-DXd 6.4 mg/kg Q3W but actually received T-DXd 5.4 mg/kg Q3W.

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

Preserved source evidence · Independent clinical review pending · Not medical advice