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NCT03248492 · BASELINE

Baseline characteristics

A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1) · Source last updated 2025-06-26

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
      50
    2. group Id
      BG001
      value
      48
    3. group Id
      BG002
      value
      21
    4. group Id
      BG003
      value
      130
    5. group Id
      BG004
      value
      4
    6. group Id
      BG005
      value
      253
    units
    Participants
groups
  1. description
    T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
    id
    BG000
    title
    Part 1: DS-8201a Low Dose
  2. description
    T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
    id
    BG001
    title
    Part 1: DS-8201a Medium Dose
  3. description
    T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
    id
    BG002
    title
    Part 1: DS-8201a High Dose
  4. description
    All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 2a in the continuation phase.
    id
    BG003
    title
    Part 2a: DS-8201a Low Dose
  5. description
    All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 2b in the continuation phase.
    id
    BG004
    title
    Part 2b (Exploratory): DS-8201a Low Dose
  6. description
    Total of all reporting groups
    id
    BG005
    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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          101
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          189
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          29
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          64
        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
          11.3
          value
          57.9
        2. group Id
          BG001
          spread
          13.0
          value
          55.8
        3. group Id
          BG002
          spread
          10.5
          value
          54.4
        4. group Id
          BG003
          spread
          11.9
          value
          55.4
        5. group Id
          BG004
          spread
          9.2
          value
          49.8
        6. group Id
          BG005
          spread
          11.8
          value
          55.8
    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
          50
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          130
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          253
        title
        Female
      2. 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
        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
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          47
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          104
        title
        Asian
      3. 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
          0
        6. group Id
          BG005
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          76
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          132
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          4
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          5
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          25
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          40
      title
      South Korea
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          9
      title
      Belgium
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          36
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          77
      title
      United States
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          56
      title
      Japan
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          10
      title
      Italy
    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
          12
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          12
      title
      United Kingdom
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          20
      title
      France
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          29
      title
      Spain
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      50
    2. group Id
      BG001
      value
      48
    3. group Id
      BG002
      value
      21
    4. group Id
      BG003
      value
      130
    5. group Id
      BG004
      value
      4
    6. group Id
      BG005
      value
      253
    units
    Participants
groups
  1. description
    T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a low dose (5.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
    id
    BG000
    title
    Part 1: DS-8201a Low Dose
  2. description
    T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a medium dose (6.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
    id
    BG001
    title
    Part 1: DS-8201a Medium Dose
  3. description
    T-DM1 resistant/refractory (R/R) participants randomized to receive DS-8201a high dose (7.4 mg/kg) in the pharmacokinetic (PK) and dose-finding phases.
    id
    BG002
    title
    Part 1: DS-8201a High Dose
  4. description
    All T-DM1 resistant/refractory (R/R) participants who were treated at the recommended (5.4 mg/kg) dose in Part 2a in the continuation phase.
    id
    BG003
    title
    Part 2a: DS-8201a Low Dose
  5. description
    All participants who were previously treated with T-DM1 and were randomized to receive DS8201a low dose (5.4 mg/kg) in Part 2b in the continuation phase.
    id
    BG004
    title
    Part 2b (Exploratory): DS-8201a Low Dose
  6. description
    Total of all reporting groups
    id
    BG005
    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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          35
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          101
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          189
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          29
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          64
        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
          11.3
          value
          57.9
        2. group Id
          BG001
          spread
          13.0
          value
          55.8
        3. group Id
          BG002
          spread
          10.5
          value
          54.4
        4. group Id
          BG003
          spread
          11.9
          value
          55.4
        5. group Id
          BG004
          spread
          9.2
          value
          49.8
        6. group Id
          BG005
          spread
          11.8
          value
          55.8
    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
          50
        2. group Id
          BG001
          value
          48
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          130
        5. group Id
          BG004
          value
          4
        6. group Id
          BG005
          value
          253
        title
        Female
      2. 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
        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
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          47
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          104
        title
        Asian
      3. 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
          0
        6. group Id
          BG005
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          5
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          24
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          76
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          132
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          4
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          5
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          25
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          40
      title
      South Korea
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          7
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          9
      title
      Belgium
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          36
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          77
      title
      United States
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          14
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          56
      title
      Japan
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          10
      title
      Italy
    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
          12
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          12
      title
      United Kingdom
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          20
      title
      France
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          29
      title
      Spain
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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

Preserved source evidence · Not medical advice