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NCT03498716 · BASELINE

Baseline characteristics

A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer · Source last updated 2024-08-21

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
      1098
    2. group Id
      BG001
      value
      1101
    3. group Id
      BG002
      value
      2199
    units
    Participants
groups
  1. description
    Participants were administered paclitaxel, 80 mg/m\^2, IV infusion QW for maximum of 36 weeks followed by dose-dense doxorubicin, 60 mg/m\^2 or dose-dense epirubicin, 90 mg/m\^2 IV (investigator's choice) plus cyclophosphamide, 600 mg/m\^2, IV repeated every Q2W for a maximum of 20 weeks supported with G-CSF or GM-CSF treatment.
    id
    BG000
    title
    Chemotherapy
  2. description
    Participants were administered atezolizumab 840 mg, IV infusion, Q2W in combination with chemotherapy (paclitaxel 80 mg/m\^2, IV infusion QW for maximum of 22 weeks followed by dose-dense doxorubicin, 60 mg/m\^2 or dose-dense epirubicin, 90 mg/m\^2, IV (investigator's choice) plus cyclophosphamide, 600 mg/m\^2, IV repeated Q2W for maximum of 17 weeks supported with G-CSF or GM-CSF treatment followed by atezolizumab, 1200 mg IV infusion every Q3W as a maintenance therapy to complete 1 year of atezolizumab treatment from the first dose.
    id
    BG001
    title
    Atezolizumab and Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.4
          value
          52.8
        2. group Id
          BG001
          spread
          11.9
          value
          52.3
        3. group Id
          BG002
          spread
          11.6
          value
          52.5
    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
          1094
        2. group Id
          BG001
          value
          1101
        3. group Id
          BG002
          value
          2195
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        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
          100
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          175
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          906
        2. group Id
          BG001
          value
          950
        3. group Id
          BG002
          value
          1856
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          168
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          57
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          401
        2. group Id
          BG001
          value
          423
        3. group Id
          BG002
          value
          824
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          10
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          567
        2. group Id
          BG001
          value
          554
        3. group Id
          BG002
          value
          1121
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          86
        3. group Id
          BG002
          value
          185
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Intent-to-Treat (ITT) population included all randomized participants, whether or not the assigned study treatment was received.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      1098
    2. group Id
      BG001
      value
      1101
    3. group Id
      BG002
      value
      2199
    units
    Participants
groups
  1. description
    Participants were administered paclitaxel, 80 mg/m\^2, IV infusion QW for maximum of 36 weeks followed by dose-dense doxorubicin, 60 mg/m\^2 or dose-dense epirubicin, 90 mg/m\^2 IV (investigator's choice) plus cyclophosphamide, 600 mg/m\^2, IV repeated every Q2W for a maximum of 20 weeks supported with G-CSF or GM-CSF treatment.
    id
    BG000
    title
    Chemotherapy
  2. description
    Participants were administered atezolizumab 840 mg, IV infusion, Q2W in combination with chemotherapy (paclitaxel 80 mg/m\^2, IV infusion QW for maximum of 22 weeks followed by dose-dense doxorubicin, 60 mg/m\^2 or dose-dense epirubicin, 90 mg/m\^2, IV (investigator's choice) plus cyclophosphamide, 600 mg/m\^2, IV repeated Q2W for maximum of 17 weeks supported with G-CSF or GM-CSF treatment followed by atezolizumab, 1200 mg IV infusion every Q3W as a maintenance therapy to complete 1 year of atezolizumab treatment from the first dose.
    id
    BG001
    title
    Atezolizumab and Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          11.4
          value
          52.8
        2. group Id
          BG001
          spread
          11.9
          value
          52.3
        3. group Id
          BG002
          spread
          11.6
          value
          52.5
    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
          1094
        2. group Id
          BG001
          value
          1101
        3. group Id
          BG002
          value
          2195
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        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
          100
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          175
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          906
        2. group Id
          BG001
          value
          950
        3. group Id
          BG002
          value
          1856
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          76
        3. group Id
          BG002
          value
          168
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          57
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          401
        2. group Id
          BG001
          value
          423
        3. group Id
          BG002
          value
          824
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          10
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          567
        2. group Id
          BG001
          value
          554
        3. group Id
          BG002
          value
          1121
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          86
        3. group Id
          BG002
          value
          185
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
Intent-to-Treat (ITT) population included all randomized participants, whether or not the assigned study treatment was received.

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Preserved source evidence · Not medical advice