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NCT04644237 · BASELINE

Baseline characteristics

Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC) · Source last updated 2025-11-21

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
      102
    2. group Id
      BG001
      value
      50
    3. group Id
      BG002
      value
      152
    units
    Participants
groups
  1. description
    Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
    id
    BG000
    title
    Trastuzumab Deruxtecan 5.4 mg/kg
  2. description
    Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
    id
    BG001
    title
    Trastuzumab Deruxtecan 6.4 mg/kg
  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
          62
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          97
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          55
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.59
          value
          59.8
        2. group Id
          BG001
          spread
          12.14
          value
          59.5
        3. group Id
          BG002
          spread
          11.73
          value
          59.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          99
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          53
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. 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
      2. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          96
        title
        Asian
      3. 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
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          28
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          26
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
The baseline demographic characteristics were assessed in the Full Analysis Set.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      102
    2. group Id
      BG001
      value
      50
    3. group Id
      BG002
      value
      152
    units
    Participants
groups
  1. description
    Participants randomized to receive trastuzumab deruxtecan 5.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
    id
    BG000
    title
    Trastuzumab Deruxtecan 5.4 mg/kg
  2. description
    Participants randomized to receive trastuzumab deruxtecan 6.4 mg/kg, administered by intravenous infusion every 3 weeks (Q3W).
    id
    BG001
    title
    Trastuzumab Deruxtecan 6.4 mg/kg
  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
          62
        2. group Id
          BG001
          value
          35
        3. group Id
          BG002
          value
          97
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          55
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.59
          value
          59.8
        2. group Id
          BG001
          spread
          12.14
          value
          59.5
        3. group Id
          BG002
          spread
          11.73
          value
          59.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          99
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          53
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. 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
      2. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          96
        title
        Asian
      3. 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
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          28
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          26
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
The baseline demographic characteristics were assessed in the Full Analysis Set.

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

Preserved source evidence · Not medical advice