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NCT04602078 · BASELINE

Baseline characteristics

Study of Atezolizumab Combined With Split-dose Gemcitabine Plus Cisplatin in Urothelial Carcinoma · Source last updated 2025-04-24

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
      66
    units
    Participants
groups
  1. description
    Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit. Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles. Atezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit. Gemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles. Cisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
    id
    BG000
    title
    AUREA Single-arm
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          49
          upper Limit
          85
          value
          71
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          57
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. denoms
      1. counts
        1. group Id
          BG000
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          66
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
      title
      Spain
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        title
        Score 0
      2. measurements
        1. group Id
          BG000
          value
          34
        title
        Score 1
      3. measurements
        1. group Id
          BG000
          value
          15
        title
        Score 2
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
    description
    Scale validated by the World Health Organization (WHO) to assess the quality of life of cancer patients. The scale ranges from 0, patient fully active, to 5, patient dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group performance status (ECOG-PS)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        title
        Upper tract
      2. measurements
        1. group Id
          BG000
          value
          55
        title
        Lower tract
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
    description
    Location of the primary tumor in the genitourinary tract: The upper tract was defined as the renal pelvis or ureter, and the lower tract as the bladder and urethra.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Site of the primary tumor
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        title
        Locally advanced
      2. measurements
        1. group Id
          BG000
          value
          58
        title
        Metastatic
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
    description
    Measures the extend of spread of the disease at the time of inclusion
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stage at inclusion
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          44
        title
        Affected
      2. measurements
        1. group Id
          BG000
          value
          22
        title
        Not affected
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
      title
      Lymph nodes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        title
        Affected
      2. measurements
        1. group Id
          BG000
          value
          30
        title
        Not affected
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
      title
      Lung
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        title
        Affected
      2. measurements
        1. group Id
          BG000
          value
          46
        title
        Not affected
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
      title
      Bone
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        title
        Affected
      2. measurements
        1. group Id
          BG000
          value
          54
        title
        Not affected
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
      title
      Liver
    description
    Percentage of patients with organs affected by the disease. A patient may have more than 1 oragan affected
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Metastatic locations
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          51
        title
        No
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
      title
      ECOG 2
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          30
        title
        No
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
      title
      Age > 70 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          33
        title
        No
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
      title
      creatinine clearance 30-60 μmol/L
    description
    Criteria to consider patients not eligible for full doses of cisplatin. A patient may have more than one reason to be considered ineligible.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Reason unfit for full dose chemotherapy
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          58
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          8
        title
        No
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
      title
      Surgery
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          57
        title
        No
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
      title
      Radiotherapy
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior local therapy
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        title
        Positive
      2. measurements
        1. group Id
          BG000
          value
          26
        title
        Negative
      3. measurements
        1. group Id
          BG000
          value
          26
        title
        Unknown
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
    description
    PD-L1, quantified using immunohistochemistry assays, is currently the most widely validated, used and accepted biomarker to guide the selection of patients to receive immunotherapy such as atezolizumab in this trial. Positivity indicates high expression of this biomarker and it has been shown to correlate with eficacy of immunotherapy in some tumor types. Negativity usually correlatess with worse prognosis to immunotherapy. The prognostic value of PL-L1 in many cancer types is still under study.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PD-L1 status
    unit Of Measure
    Participants
population Description
Full Analysis Set
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      66
    units
    Participants
groups
  1. description
    Atezolizumab (1200 mg) intravenously administered every 21 days (one cycle) up to disease progression, unacceptable toxicity or absence of clinical benefit. Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle plus Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles. Atezolizumab 1200 mg/m2: Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit. Gemcitabine 1000 mg/m2: Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles. Cisplatin 70 mg/m2: Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
    id
    BG000
    title
    AUREA Single-arm
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          49
          upper Limit
          85
          value
          71
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          57
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. denoms
      1. counts
        1. group Id
          BG000
          value
          0
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Race and Ethnicity were not collected from any participant.
    title
    Race and Ethnicity Not Collected
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          66
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
      title
      Spain
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        title
        Score 0
      2. measurements
        1. group Id
          BG000
          value
          34
        title
        Score 1
      3. measurements
        1. group Id
          BG000
          value
          15
        title
        Score 2
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
    description
    Scale validated by the World Health Organization (WHO) to assess the quality of life of cancer patients. The scale ranges from 0, patient fully active, to 5, patient dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group performance status (ECOG-PS)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        title
        Upper tract
      2. measurements
        1. group Id
          BG000
          value
          55
        title
        Lower tract
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
    description
    Location of the primary tumor in the genitourinary tract: The upper tract was defined as the renal pelvis or ureter, and the lower tract as the bladder and urethra.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Site of the primary tumor
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        title
        Locally advanced
      2. measurements
        1. group Id
          BG000
          value
          58
        title
        Metastatic
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
    description
    Measures the extend of spread of the disease at the time of inclusion
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stage at inclusion
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          44
        title
        Affected
      2. measurements
        1. group Id
          BG000
          value
          22
        title
        Not affected
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
      title
      Lymph nodes
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        title
        Affected
      2. measurements
        1. group Id
          BG000
          value
          30
        title
        Not affected
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
      title
      Lung
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          20
        title
        Affected
      2. measurements
        1. group Id
          BG000
          value
          46
        title
        Not affected
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
      title
      Bone
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        title
        Affected
      2. measurements
        1. group Id
          BG000
          value
          54
        title
        Not affected
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
      title
      Liver
    description
    Percentage of patients with organs affected by the disease. A patient may have more than 1 oragan affected
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Metastatic locations
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          51
        title
        No
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
      title
      ECOG 2
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          36
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          30
        title
        No
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
      title
      Age > 70 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          33
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          33
        title
        No
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
      title
      creatinine clearance 30-60 μmol/L
    description
    Criteria to consider patients not eligible for full doses of cisplatin. A patient may have more than one reason to be considered ineligible.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Reason unfit for full dose chemotherapy
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          58
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          8
        title
        No
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
      title
      Surgery
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          57
        title
        No
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
      title
      Radiotherapy
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior local therapy
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        title
        Positive
      2. measurements
        1. group Id
          BG000
          value
          26
        title
        Negative
      3. measurements
        1. group Id
          BG000
          value
          26
        title
        Unknown
      denoms
      1. counts
        1. group Id
          BG000
          value
          66
        units
        Participants
    description
    PD-L1, quantified using immunohistochemistry assays, is currently the most widely validated, used and accepted biomarker to guide the selection of patients to receive immunotherapy such as atezolizumab in this trial. Positivity indicates high expression of this biomarker and it has been shown to correlate with eficacy of immunotherapy in some tumor types. Negativity usually correlatess with worse prognosis to immunotherapy. The prognostic value of PL-L1 in many cancer types is still under study.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PD-L1 status
    unit Of Measure
    Participants
population Description
Full Analysis Set

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