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NCT02400476 · BASELINE

Baseline characteristics

An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide · Source last updated 2022-05-06

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
      137
    2. group Id
      BG001
      value
      64
    3. group Id
      BG002
      value
      136
    4. group Id
      BG003
      value
      104
    5. group Id
      BG004
      value
      60
    6. group Id
      BG005
      value
      62
    7. group Id
      BG006
      value
      563
    units
    Participants
groups
  1. description
    240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Loperamide daily for two 28-day cycles and then as needed. Neratinib Loperamide
    id
    BG000
    title
    Loperamide
  2. description
    240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Anti-inflammatory treatment for 1 cycle and Loperamide to be administered daily for two 28-day cycles and then as needed, thereafter. Neratinib Loperamide Budesonide: 9 mg extended release tablets once daily with or without food for 28 days
    id
    BG001
    title
    Budesonide and Loperamide
  3. description
    240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered 1 cycle and then as needed, thereafter. Neratinib Loperamide Colestipol: 2 g twice daily with or without food for one 28 day cycle
    id
    BG002
    title
    Colestipol and Loperamide
  4. description
    240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered as needed. Neratinib Loperamide Colestipol: 2 g twice daily with or without food for one 28 day cycle
    id
    BG003
    title
    Colestipol With Loperamide as Needed
  5. description
    120 mg Neratinib for Week 1, followed by 160 mg Neratinib starting for Week 2, followed by 240 mg Neratinib starting at Week 3 and thereafter (C1D15 to End of Treatment). Loperamide administered as needed. Neratinib Loperamide
    id
    BG004
    title
    Neratinib Dose Escalation 1
  6. description
    160 mg neratinib for the first 2 weeks, followed by 200 mg neratinib for the next 2 weeks, followed by 240 mg neratinib thereafter (C2D1 to End of treatment. Loperamide will be administered on an as-needed basis only. Neratinib Loperamide
    id
    BG005
    title
    Neratinib Dose Escalation 2
  7. description
    Total of all reporting groups
    id
    BG006
    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
        7. group Id
          BG006
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          116
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          117
        4. group Id
          BG003
          value
          93
        5. group Id
          BG004
          value
          51
        6. group Id
          BG005
          value
          52
        7. group Id
          BG006
          value
          487
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          76
        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
          11.06
          value
          53.39
        2. group Id
          BG001
          spread
          10.55
          value
          49.11
        3. group Id
          BG002
          spread
          11.08
          value
          52.49
        4. group Id
          BG003
          spread
          10.23
          value
          51.94
        5. group Id
          BG004
          spread
          10.71
          value
          51.90
        6. group Id
          BG005
          spread
          10.15
          value
          53.82
        7. group Id
          BG006
          spread
          10.76
          value
          52.31
    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
          137
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          133
        4. group Id
          BG003
          value
          104
        5. group Id
          BG004
          value
          60
        6. group Id
          BG005
          value
          62
        7. group Id
          BG006
          value
          560
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        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
          113
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          96
        4. group Id
          BG003
          value
          80
        5. group Id
          BG004
          value
          53
        6. group Id
          BG005
          value
          52
        7. group Id
          BG006
          value
          444
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          36
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          38
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        title
        American Indian or Alaska Native
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          4
        title
        Native Hawaiian or Other Pacific Islander
      6. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          18
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          5
        title
        Unknown
      8. 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
          1
        7. group Id
          BG006
          value
          1
        title
        Missing
      9. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          15
        title
        Not Reported
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          27
      title
      Canada
    2. 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
          4
        7. group Id
          BG006
          value
          4
      title
      Austria
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          115
        4. group Id
          BG003
          value
          83
        5. group Id
          BG004
          value
          20
        6. group Id
          BG005
          value
          11
        7. group Id
          BG006
          value
          413
      title
      United States
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          23
        6. group Id
          BG005
          value
          18
        7. group Id
          BG006
          value
          86
      title
      Australia
    5. 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
          6
        7. group Id
          BG006
          value
          6
      title
      France
    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
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
      title
      Germany
    7. 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
          11
        6. group Id
          BG005
          value
          14
        7. group Id
          BG006
          value
          25
      title
      Spain
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      137
    2. group Id
      BG001
      value
      64
    3. group Id
      BG002
      value
      136
    4. group Id
      BG003
      value
      104
    5. group Id
      BG004
      value
      60
    6. group Id
      BG005
      value
      62
    7. group Id
      BG006
      value
      563
    units
    Participants
groups
  1. description
    240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Loperamide daily for two 28-day cycles and then as needed. Neratinib Loperamide
    id
    BG000
    title
    Loperamide
  2. description
    240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Anti-inflammatory treatment for 1 cycle and Loperamide to be administered daily for two 28-day cycles and then as needed, thereafter. Neratinib Loperamide Budesonide: 9 mg extended release tablets once daily with or without food for 28 days
    id
    BG001
    title
    Budesonide and Loperamide
  3. description
    240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered 1 cycle and then as needed, thereafter. Neratinib Loperamide Colestipol: 2 g twice daily with or without food for one 28 day cycle
    id
    BG002
    title
    Colestipol and Loperamide
  4. description
    240 mg Neratinib orally once daily with food for thirteen 28-day cycles. Colestipol for 1 cycle and loperamide to be administered as needed. Neratinib Loperamide Colestipol: 2 g twice daily with or without food for one 28 day cycle
    id
    BG003
    title
    Colestipol With Loperamide as Needed
  5. description
    120 mg Neratinib for Week 1, followed by 160 mg Neratinib starting for Week 2, followed by 240 mg Neratinib starting at Week 3 and thereafter (C1D15 to End of Treatment). Loperamide administered as needed. Neratinib Loperamide
    id
    BG004
    title
    Neratinib Dose Escalation 1
  6. description
    160 mg neratinib for the first 2 weeks, followed by 200 mg neratinib for the next 2 weeks, followed by 240 mg neratinib thereafter (C2D1 to End of treatment. Loperamide will be administered on an as-needed basis only. Neratinib Loperamide
    id
    BG005
    title
    Neratinib Dose Escalation 2
  7. description
    Total of all reporting groups
    id
    BG006
    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
        7. group Id
          BG006
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          116
        2. group Id
          BG001
          value
          58
        3. group Id
          BG002
          value
          117
        4. group Id
          BG003
          value
          93
        5. group Id
          BG004
          value
          51
        6. group Id
          BG005
          value
          52
        7. group Id
          BG006
          value
          487
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          9
        6. group Id
          BG005
          value
          10
        7. group Id
          BG006
          value
          76
        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
          11.06
          value
          53.39
        2. group Id
          BG001
          spread
          10.55
          value
          49.11
        3. group Id
          BG002
          spread
          11.08
          value
          52.49
        4. group Id
          BG003
          spread
          10.23
          value
          51.94
        5. group Id
          BG004
          spread
          10.71
          value
          51.90
        6. group Id
          BG005
          spread
          10.15
          value
          53.82
        7. group Id
          BG006
          spread
          10.76
          value
          52.31
    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
          137
        2. group Id
          BG001
          value
          64
        3. group Id
          BG002
          value
          133
        4. group Id
          BG003
          value
          104
        5. group Id
          BG004
          value
          60
        6. group Id
          BG005
          value
          62
        7. group Id
          BG006
          value
          560
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          3
        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
          113
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          96
        4. group Id
          BG003
          value
          80
        5. group Id
          BG004
          value
          53
        6. group Id
          BG005
          value
          52
        7. group Id
          BG006
          value
          444
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          8
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          36
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          38
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        title
        American Indian or Alaska Native
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          4
        title
        Native Hawaiian or Other Pacific Islander
      6. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          9
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          18
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          5
        title
        Unknown
      8. 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
          1
        7. group Id
          BG006
          value
          1
        title
        Missing
      9. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          15
        title
        Not Reported
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          10
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          7
        7. group Id
          BG006
          value
          27
      title
      Canada
    2. 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
          4
        7. group Id
          BG006
          value
          4
      title
      Austria
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          115
        4. group Id
          BG003
          value
          83
        5. group Id
          BG004
          value
          20
        6. group Id
          BG005
          value
          11
        7. group Id
          BG006
          value
          413
      title
      United States
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          11
        5. group Id
          BG004
          value
          23
        6. group Id
          BG005
          value
          18
        7. group Id
          BG006
          value
          86
      title
      Australia
    5. 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
          6
        7. group Id
          BG006
          value
          6
      title
      France
    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
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        7. group Id
          BG006
          value
          2
      title
      Germany
    7. 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
          11
        6. group Id
          BG005
          value
          14
        7. group Id
          BG006
          value
          25
      title
      Spain
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice