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NCT02302807 · BASELINE

Baseline characteristics

A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211] · Source last updated 2019-08-01

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
      464
    2. group Id
      BG001
      value
      467
    3. group Id
      BG002
      value
      931
    units
    Participants
groups
  1. description
    Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m\^2), paclitaxel 175 mg/m\^2, or docetaxel 75 mg/m\^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
    id
    BG000
    title
    Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)
  2. description
    Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
    id
    BG001
    title
    Atezolizumab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.3
          value
          66.1
        2. group Id
          BG001
          spread
          9.6
          value
          65.9
        3. group Id
          BG002
          spread
          9.4
          value
          66.0
    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
          103
        2. group Id
          BG001
          value
          110
        3. group Id
          BG002
          value
          213
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          361
        2. group Id
          BG001
          value
          357
        3. group Id
          BG002
          value
          718
        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
          16
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          29
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          368
        2. group Id
          BG001
          value
          363
        3. group Id
          BG002
          value
          731
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          171
        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
          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
          55
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          118
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          336
        2. group Id
          BG001
          value
          335
        3. group Id
          BG002
          value
          671
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          138
        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
      464
    2. group Id
      BG001
      value
      467
    3. group Id
      BG002
      value
      931
    units
    Participants
groups
  1. description
    Participants randomized to the chemotherapy arm received vinflunine, paclitaxel, or docetaxel per the investigators choice. Vinflunine 320 milligrams per square meter (mg/m\^2), paclitaxel 175 mg/m\^2, or docetaxel 75 mg/m\^2 were administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.
    id
    BG000
    title
    Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)
  2. description
    Atezolizumab was administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants received atezolizumab as long as they continued to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
    id
    BG001
    title
    Atezolizumab
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.3
          value
          66.1
        2. group Id
          BG001
          spread
          9.6
          value
          65.9
        3. group Id
          BG002
          spread
          9.4
          value
          66.0
    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
          103
        2. group Id
          BG001
          value
          110
        3. group Id
          BG002
          value
          213
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          361
        2. group Id
          BG001
          value
          357
        3. group Id
          BG002
          value
          718
        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
          16
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          29
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          368
        2. group Id
          BG001
          value
          363
        3. group Id
          BG002
          value
          731
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          91
        3. group Id
          BG002
          value
          171
        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
          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
          55
        2. group Id
          BG001
          value
          63
        3. group Id
          BG002
          value
          118
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          336
        2. group Id
          BG001
          value
          335
        3. group Id
          BG002
          value
          671
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          70
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          138
        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