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NCT00878709 · BASELINE

Baseline characteristics

Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer · Source last updated 2021-06-11

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
      1420
    2. group Id
      BG001
      value
      1420
    3. group Id
      BG002
      value
      2840
    units
    Participants
groups
  1. description
    Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
    id
    BG000
    title
    Neratinib
  2. description
    Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.08
          value
          52.3
        2. group Id
          BG001
          spread
          10.28
          value
          52.3
        3. group Id
          BG002
          spread
          10.18
          value
          52.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1420
        2. group Id
          BG001
          value
          1420
        3. group Id
          BG002
          value
          2840
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          188
        2. group Id
          BG001
          value
          197
        3. group Id
          BG002
          value
          385
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          74
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1165
        2. group Id
          BG001
          value
          1135
        3. group Id
          BG002
          value
          2300
      title
      White
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          81
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      1420
    2. group Id
      BG001
      value
      1420
    3. group Id
      BG002
      value
      2840
    units
    Participants
groups
  1. description
    Patients who completed prior adjuvant trastuzumab received six 40 mg neratinib tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
    id
    BG000
    title
    Neratinib
  2. description
    Patients who completed prior adjuvant trastuzumab received six 40 mg placebo tablets (240 mg) taken orally once daily with food, preferably in the morning, continuously for one year. Therapy continued until unacceptable toxicity, recurrent disease, death, or withdrawal of consent occurred.
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.08
          value
          52.3
        2. group Id
          BG001
          spread
          10.28
          value
          52.3
        3. group Id
          BG002
          spread
          10.18
          value
          52.3
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1420
        2. group Id
          BG001
          value
          1420
        3. group Id
          BG002
          value
          2840
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          188
        2. group Id
          BG001
          value
          197
        3. group Id
          BG002
          value
          385
      title
      Asian
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          74
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1165
        2. group Id
          BG001
          value
          1135
        3. group Id
          BG002
          value
          2300
      title
      White
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          81
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Intent to treat (ITT) population included all participants who were randomized regardless of whether they received any study treatment.

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Preserved source evidence · Not medical advice