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NCT03125902 · BASELINE

Baseline characteristics

A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC) · Source last updated 2024-03-26

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
      220
    2. group Id
      BG001
      value
      431
    3. group Id
      BG002
      value
      651
    units
    Participants
groups
  1. description
    Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    id
    BG000
    title
    Placebo and Paclitaxel
  2. description
    Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    id
    BG001
    title
    Atezolizumab and Paclitaxel
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          176
        2. group Id
          BG001
          value
          322
        3. group Id
          BG002
          value
          498
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          109
        3. group Id
          BG002
          value
          153
        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
          12.2
          value
          52.7
        2. group Id
          BG001
          spread
          12.6
          value
          54.8
        3. group Id
          BG002
          spread
          12.5
          value
          54.0
    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
          220
        2. group Id
          BG001
          value
          430
        3. group Id
          BG002
          value
          650
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        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
          23
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          67
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          174
        2. group Id
          BG001
          value
          332
        3. group Id
          BG002
          value
          506
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          78
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    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
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          123
        3. group Id
          BG002
          value
          189
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          31
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          128
        2. group Id
          BG001
          value
          246
        3. group Id
          BG002
          value
          374
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          51
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      220
    2. group Id
      BG001
      value
      431
    3. group Id
      BG002
      value
      651
    units
    Participants
groups
  1. description
    Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m\^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    id
    BG000
    title
    Placebo and Paclitaxel
  2. description
    Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m\^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.
    id
    BG001
    title
    Atezolizumab and Paclitaxel
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          176
        2. group Id
          BG001
          value
          322
        3. group Id
          BG002
          value
          498
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          44
        2. group Id
          BG001
          value
          109
        3. group Id
          BG002
          value
          153
        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
          12.2
          value
          52.7
        2. group Id
          BG001
          spread
          12.6
          value
          54.8
        3. group Id
          BG002
          spread
          12.5
          value
          54.0
    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
          220
        2. group Id
          BG001
          value
          430
        3. group Id
          BG002
          value
          650
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        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
          23
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          67
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          174
        2. group Id
          BG001
          value
          332
        3. group Id
          BG002
          value
          506
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          55
        3. group Id
          BG002
          value
          78
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    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
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          123
        3. group Id
          BG002
          value
          189
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          31
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          128
        2. group Id
          BG001
          value
          246
        3. group Id
          BG002
          value
          374
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          51
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice