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NCT03513952 · BASELINE

Baseline characteristics

Atezolizumab and CYT107 in Treating Participants With Locally Advanced, Inoperable, or Metastatic Urothelial Carcinoma · Source last updated 2024-07-26

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
      19
    2. group Id
      BG001
      value
      21
    3. group Id
      BG002
      value
      7
    4. group Id
      BG003
      value
      47
    units
    Participants
groups
  1. description
    Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
    id
    BG000
    title
    Group 1 (CYT107, Atezolizumab)
  2. description
    Patients receive atezolizumab on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV
    id
    BG001
    title
    Group 2 (Atezolizumab)
  3. description
    Patients were not randomized; they were assigned to the experimental arm treatment (atezolizumab + CYT107). Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
    id
    BG002
    title
    Safety Run in Phase
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.2
          value
          65.7
        2. group Id
          BG001
          spread
          8.5
          value
          66.3
        3. group Id
          BG002
          spread
          11
          value
          59.7
        4. group Id
          BG003
          spread
          9.3
          value
          65.1
    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
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          9
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          38
        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
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          44
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        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
        4. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. 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
        title
        Asian
      3. 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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          44
        title
        White
      6. 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
        title
        More than one race
      7. 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
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          47
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      19
    2. group Id
      BG001
      value
      21
    3. group Id
      BG002
      value
      7
    4. group Id
      BG003
      value
      47
    units
    Participants
groups
  1. description
    Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
    id
    BG000
    title
    Group 1 (CYT107, Atezolizumab)
  2. description
    Patients receive atezolizumab on day 1 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV
    id
    BG001
    title
    Group 2 (Atezolizumab)
  3. description
    Patients were not randomized; they were assigned to the experimental arm treatment (atezolizumab + CYT107). Patients receive CYT107 on days 1, 8, 15, and 22, and atezolizumab on day 8 of cycle 1. Following cycle 1, patients receive atezolizumab on day 1. Cycles with atezolizumab repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Atezolizumab: Given IV Glycosylated Recombinant Human Interleukin-7: Given IM
    id
    BG002
    title
    Safety Run in Phase
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.2
          value
          65.7
        2. group Id
          BG001
          spread
          8.5
          value
          66.3
        3. group Id
          BG002
          spread
          11
          value
          59.7
        4. group Id
          BG003
          spread
          9.3
          value
          65.1
    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
          3
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          9
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          38
        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
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          44
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        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
        4. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. 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
        title
        Asian
      3. 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
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          44
        title
        White
      6. 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
        title
        More than one race
      7. 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
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          47
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice