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NCT02853305 · BASELINE

Baseline characteristics

Study of Pembrolizumab With or Without Platinum-based Combination Chemotherapy Versus Chemotherapy Alone in Urothelial Carcinoma (MK-3475-361/KEYNOTE-361) · Source last updated 2023-09-08

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
      351
    2. group Id
      BG001
      value
      307
    3. group Id
      BG002
      value
      352
    4. group Id
      BG003
      value
      1010
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
    id
    BG000
    title
    Pembrolizumab + ST Chemotherapy (Pembro Combo)
  2. description
    Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses. Eligible participants who stopped pembrolizumab with SD or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
    id
    BG001
    title
    Pembrolizumab (Pembro)
  3. description
    Participants received ST chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.
    id
    BG002
    title
    ST Chemotherapy (Chemo)
  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
          68.3
        2. group Id
          BG001
          spread
          10.1
          value
          67.0
        3. group Id
          BG002
          spread
          9.6
          value
          68.0
        4. group Id
          BG003
          spread
          9.6
          value
          67.8
    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
          79
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          90
        4. group Id
          BG003
          value
          248
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          272
        2. group Id
          BG001
          value
          228
        3. group Id
          BG002
          value
          262
        4. group Id
          BG003
          value
          762
        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
          26
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          32
        4. group Id
          BG003
          value
          83
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          269
        2. group Id
          BG001
          value
          231
        3. group Id
          BG002
          value
          261
        4. group Id
          BG003
          value
          761
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          59
        4. group Id
          BG003
          value
          166
        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
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          70
        4. group Id
          BG003
          value
          181
        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
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          243
        2. group Id
          BG001
          value
          212
        3. group Id
          BG002
          value
          235
        4. group Id
          BG003
          value
          690
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          42
        4. group Id
          BG003
          value
          126
        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
          192
        2. group Id
          BG001
          value
          148
        3. group Id
          BG002
          value
          193
        4. group Id
          BG003
          value
          533
      title
      PD-L1 CPS<10
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          159
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          159
        4. group Id
          BG003
          value
          477
      title
      PD-L1 CPS≥10
    description
    The Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) Status indicates tumor PD-L1 positivity using both tumor cells and inflammatory cells that are positive for PD-L1 by immunohistochemistry (IHC). Higher percentages of PD-L1 CPS staining corresponded to higher positivity of PD-L1 on a tumor. The number of participants with CPS \<10% and CPS ≥10% at baseline randomization by Interactive Voice Response System (IVRS) is presented
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PD-L1 CPS Status-IVRS
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          160
        2. group Id
          BG001
          value
          138
        3. group Id
          BG002
          value
          160
        4. group Id
          BG003
          value
          458
      title
      Cisplatin
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          191
        2. group Id
          BG001
          value
          169
        3. group Id
          BG002
          value
          192
        4. group Id
          BG003
          value
          552
      title
      Carboplatin
    description
    The Investigator's choice of chemotherapy drug (cisplatin or carboplatin) at baseline randomization by IVRS is presented.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Investigator Choice of Cisplatin or Carboplatin - IVRS
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      351
    2. group Id
      BG001
      value
      307
    3. group Id
      BG002
      value
      352
    4. group Id
      BG003
      value
      1010
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for a maximum of 35 doses PLUS standard therapy (ST) chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle, OR carboplatin at an area under the curve 5 (AUC 5) (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle + gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle. Eligible participants who stopped pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
    id
    BG000
    title
    Pembrolizumab + ST Chemotherapy (Pembro Combo)
  2. description
    Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle for a maximum of 35 doses. Eligible participants who stopped pembrolizumab with SD or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
    id
    BG001
    title
    Pembrolizumab (Pembro)
  3. description
    Participants received ST chemotherapy with EITHER cisplatin 70 mg/m\^2 IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine IV infusion 1,000 mg/m\^2 on Day 1 and Day 8 of each 3-week cycle OR carboplatin at AUC 5 (or AUC 4.5 if required per local guidelines) IV on Day 1 (or Day 2 if required per local guidelines) of each 3-week cycle plus gemcitabine 1,000 mg/m\^2 IV on Day 1 and Day 8 of each 3-week cycle.
    id
    BG002
    title
    ST Chemotherapy (Chemo)
  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
          68.3
        2. group Id
          BG001
          spread
          10.1
          value
          67.0
        3. group Id
          BG002
          spread
          9.6
          value
          68.0
        4. group Id
          BG003
          spread
          9.6
          value
          67.8
    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
          79
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          90
        4. group Id
          BG003
          value
          248
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          272
        2. group Id
          BG001
          value
          228
        3. group Id
          BG002
          value
          262
        4. group Id
          BG003
          value
          762
        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
          26
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          32
        4. group Id
          BG003
          value
          83
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          269
        2. group Id
          BG001
          value
          231
        3. group Id
          BG002
          value
          261
        4. group Id
          BG003
          value
          761
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          51
        3. group Id
          BG002
          value
          59
        4. group Id
          BG003
          value
          166
        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
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          64
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          70
        4. group Id
          BG003
          value
          181
        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
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          243
        2. group Id
          BG001
          value
          212
        3. group Id
          BG002
          value
          235
        4. group Id
          BG003
          value
          690
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          42
        3. group Id
          BG002
          value
          42
        4. group Id
          BG003
          value
          126
        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
          192
        2. group Id
          BG001
          value
          148
        3. group Id
          BG002
          value
          193
        4. group Id
          BG003
          value
          533
      title
      PD-L1 CPS<10
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          159
        2. group Id
          BG001
          value
          159
        3. group Id
          BG002
          value
          159
        4. group Id
          BG003
          value
          477
      title
      PD-L1 CPS≥10
    description
    The Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) Status indicates tumor PD-L1 positivity using both tumor cells and inflammatory cells that are positive for PD-L1 by immunohistochemistry (IHC). Higher percentages of PD-L1 CPS staining corresponded to higher positivity of PD-L1 on a tumor. The number of participants with CPS \<10% and CPS ≥10% at baseline randomization by Interactive Voice Response System (IVRS) is presented
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PD-L1 CPS Status-IVRS
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          160
        2. group Id
          BG001
          value
          138
        3. group Id
          BG002
          value
          160
        4. group Id
          BG003
          value
          458
      title
      Cisplatin
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          191
        2. group Id
          BG001
          value
          169
        3. group Id
          BG002
          value
          192
        4. group Id
          BG003
          value
          552
      title
      Carboplatin
    description
    The Investigator's choice of chemotherapy drug (cisplatin or carboplatin) at baseline randomization by IVRS is presented.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Investigator Choice of Cisplatin or Carboplatin - IVRS
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice