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NCT03329690 · BASELINE

Baseline characteristics

DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing Gastric Cancer [DESTINY-Gastric01] · Source last updated 2022-03-18

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
      125
    2. group Id
      BG001
      value
      55
    3. group Id
      BG002
      value
      7
    4. group Id
      BG003
      value
      20
    5. group Id
      BG004
      value
      24
    6. group Id
      BG005
      value
      231
    units
    Participants
groups
  1. description
    Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
    id
    BG000
    title
    DS-8201a
  2. description
    Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
    id
    BG001
    title
    Physician's Choice Irinotecan
  3. description
    Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
    id
    BG002
    title
    Physician's Choice Paclitaxel
  4. description
    Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
    id
    BG003
    title
    Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
  5. description
    Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
    id
    BG004
    title
    Exploratory: Naïve HER2 IHC 1+, DS-8201a
  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
          55
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          17
        6. group Id
          BG005
          value
          110
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          121
        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
          10.36
          value
          64.2
        2. group Id
          BG001
          spread
          10.54
          value
          64.9
        3. group Id
          BG002
          spread
          8.96
          value
          63.4
        4. group Id
          BG003
          spread
          10.87
          value
          62.5
        5. group Id
          BG004
          spread
          12.12
          value
          55.5
        6. group Id
          BG005
          spread
          10.86
          value
          63.3
    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
          30
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          56
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          95
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          17
        6. group Id
          BG005
          value
          175
        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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          125
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          24
        6. group Id
          BG005
          value
          231
        title
        Asian
      3. 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
        Native Hawaiian or Other Pacific Islander
      4. 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
        Black or African American
      5. 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
        White
      6. 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
        More than one race
      7. 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
        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
          26
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          47
      title
      South Korea
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          184
      title
      Japan
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Baseline and demographic characteristics were assessed in the Full Analysis Set.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      125
    2. group Id
      BG001
      value
      55
    3. group Id
      BG002
      value
      7
    4. group Id
      BG003
      value
      20
    5. group Id
      BG004
      value
      24
    6. group Id
      BG005
      value
      231
    units
    Participants
groups
  1. description
    Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive DS-8201a once every 3 weeks.
    id
    BG000
    title
    DS-8201a
  2. description
    Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive irinotecan monotherapy as prescribed by the physician before enrollment.
    id
    BG001
    title
    Physician's Choice Irinotecan
  3. description
    Participants with HER2-overexpressing (IHC 3+ or IHC 2+/ISH+) advanced gastric or gastroesophageal junction adenocarcinoma, whose disease had progressed on two prior regimens, were randomized to receive paclitaxel monotherapy as prescribed by the physician before enrollment.
    id
    BG002
    title
    Physician's Choice Paclitaxel
  4. description
    Non-randomized participants with HER2 IHC 2+/ISH- advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every three weeks.
    id
    BG003
    title
    Exploratory: Naïve HER2 IHC 2+/ISH-, DS-8201a
  5. description
    Non-randomized participants with HER2 IHC 1+ advanced gastric or gastroesophageal junction adenocarcinoma who received DS-8201a once every 3 weeks.
    id
    BG004
    title
    Exploratory: Naïve HER2 IHC 1+, DS-8201a
  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
          55
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          17
        6. group Id
          BG005
          value
          110
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          31
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          121
        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
          10.36
          value
          64.2
        2. group Id
          BG001
          spread
          10.54
          value
          64.9
        3. group Id
          BG002
          spread
          8.96
          value
          63.4
        4. group Id
          BG003
          spread
          10.87
          value
          62.5
        5. group Id
          BG004
          spread
          12.12
          value
          55.5
        6. group Id
          BG005
          spread
          10.86
          value
          63.3
    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
          30
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          56
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          95
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          17
        6. group Id
          BG005
          value
          175
        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
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          125
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          24
        6. group Id
          BG005
          value
          231
        title
        Asian
      3. 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
        Native Hawaiian or Other Pacific Islander
      4. 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
        Black or African American
      5. 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
        White
      6. 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
        More than one race
      7. 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
        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
          26
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          5
        6. group Id
          BG005
          value
          47
      title
      South Korea
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          19
        6. group Id
          BG005
          value
          184
      title
      Japan
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Baseline and demographic characteristics were assessed in the Full Analysis Set.

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

Preserved source evidence · Not medical advice