Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04223856 · BASELINE

Baseline characteristics

Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer · Source last updated 2026-05-29

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
      442
    2. group Id
      BG001
      value
      444
    3. group Id
      BG002
      value
      886
    units
    Participants
groups
  1. description
    Participants received enfortumab vedotin at 1.25 mg/kg as an IV infusion over approximately 30 minutes on Days 1 and 8 of each cycle, and pembrolizumab 200 mg as an IV infusion over approximately 30 minutes on Day 1 of each cycle, after completion of the enfortumab vedotin infusion. 1 cycle = 3 weeks.
    id
    BG000
    title
    Enfortumab Vedotin + Pembrolizumab
  2. description
    Participants received gemcitabine at 1000 mg/m\^2 as an IV infusion on Days 1 and 8 of each cycle, and either cisplatin (70 mg/m\^2) or carboplatin (AUC 4.5, or AUC 5 according to local guidelines) on Day 1 of each cycle, with adequate pre- and post-hydration, by IV infusion per institutional standards. 1 cycle = 3 weeks.
    id
    BG001
    title
    Standard of Care
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.1
          value
          67.9
        2. group Id
          BG001
          spread
          9.4
          value
          68.0
        3. group Id
          BG002
          spread
          9.2
          value
          67.9
    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
          98
        2. group Id
          BG001
          value
          108
        3. group Id
          BG002
          value
          206
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          344
        2. group Id
          BG001
          value
          336
        3. group Id
          BG002
          value
          680
        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
          52
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          104
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          359
        2. group Id
          BG001
          value
          343
        3. group Id
          BG002
          value
          702
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          80
        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
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          92
        3. group Id
          BG002
          value
          191
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          10
        title
        Black or African American
      4. 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
      5. measurements
        1. group Id
          BG000
          value
          308
        2. group Id
          BG001
          value
          290
        3. group Id
          BG002
          value
          598
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        title
        Multiple
      8. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          15
        title
        Unknown
      9. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          59
        title
        Not Reported
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Intent-to-Treat (ITT) analysis set include all randomized participants. Participants were analyzed according to the treatment arm assigned at randomization regardless of the actual treatment received.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      442
    2. group Id
      BG001
      value
      444
    3. group Id
      BG002
      value
      886
    units
    Participants
groups
  1. description
    Participants received enfortumab vedotin at 1.25 mg/kg as an IV infusion over approximately 30 minutes on Days 1 and 8 of each cycle, and pembrolizumab 200 mg as an IV infusion over approximately 30 minutes on Day 1 of each cycle, after completion of the enfortumab vedotin infusion. 1 cycle = 3 weeks.
    id
    BG000
    title
    Enfortumab Vedotin + Pembrolizumab
  2. description
    Participants received gemcitabine at 1000 mg/m\^2 as an IV infusion on Days 1 and 8 of each cycle, and either cisplatin (70 mg/m\^2) or carboplatin (AUC 4.5, or AUC 5 according to local guidelines) on Day 1 of each cycle, with adequate pre- and post-hydration, by IV infusion per institutional standards. 1 cycle = 3 weeks.
    id
    BG001
    title
    Standard of Care
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.1
          value
          67.9
        2. group Id
          BG001
          spread
          9.4
          value
          68.0
        3. group Id
          BG002
          spread
          9.2
          value
          67.9
    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
          98
        2. group Id
          BG001
          value
          108
        3. group Id
          BG002
          value
          206
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          344
        2. group Id
          BG001
          value
          336
        3. group Id
          BG002
          value
          680
        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
          52
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          104
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          359
        2. group Id
          BG001
          value
          343
        3. group Id
          BG002
          value
          702
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          31
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          80
        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
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          92
        3. group Id
          BG002
          value
          191
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          10
        title
        Black or African American
      4. 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
      5. measurements
        1. group Id
          BG000
          value
          308
        2. group Id
          BG001
          value
          290
        3. group Id
          BG002
          value
          598
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          4
        title
        Multiple
      8. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          15
        title
        Unknown
      9. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          59
        title
        Not Reported
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Intent-to-Treat (ITT) analysis set include all randomized participants. Participants were analyzed according to the treatment arm assigned at randomization regardless of the actual treatment received.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice