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NCT03474107 · BASELINE

Baseline characteristics

A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301) · Source last updated 2026-01-09

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
      301
    2. group Id
      BG001
      value
      307
    3. group Id
      BG002
      value
      608
    units
    Participants
groups
  1. description
    Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
    id
    BG000
    title
    Enfortumab Vedotin 1.25 mg/kg
  2. description
    Participants received either 75 mg/m\^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m\^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m\^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
    id
    BG001
    title
    Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.11
          value
          66.52
        2. group Id
          BG001
          spread
          9.93
          value
          66.81
        3. group Id
          BG002
          spread
          9.53
          value
          66.67
    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
          63
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          138
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          238
        2. group Id
          BG001
          value
          232
        3. group Id
          BG002
          value
          470
        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
          29
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          53
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          230
        2. group Id
          BG001
          value
          238
        3. group Id
          BG002
          value
          468
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          87
        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
          97
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          200
        title
        Asian
      3. 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
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          159
        2. group Id
          BG001
          value
          155
        3. group Id
          BG002
          value
          314
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          89
        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
          120
        2. group Id
          BG001
          value
          124
        3. group Id
          BG002
          value
          244
      title
      ECOG PS=0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          181
        2. group Id
          BG001
          value
          183
        3. group Id
          BG002
          value
          364
      title
      ECOG PS=1
    description
    ECOG PS was measured on 6 point scale 0-Fully active, able to carry on all pre-disease performance without restriction 1. Restricted in physically strenuous activity but ambulatory \& able to carry out work of a light or sedentary nature 2. Ambulatory \& capable of all self-care but unable to carry out any work activities.Up \& about more than 50% of waking hours 3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours 4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair 5. Dead Participants were categorized based on ECOG PS 0 or 1
    param Type
    NUMBER
    title
    ECOG PS
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          208
        2. group Id
          BG001
          value
          212
        3. group Id
          BG002
          value
          420
      title
      Liver Metastasis=No
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          93
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          188
      title
      Liver Metastasis=Yes
    description
    Participants were categorized based on liver metastasis (yes or no).
    param Type
    NUMBER
    title
    Liver Metastasis
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          126
        2. group Id
          BG001
          value
          129
        3. group Id
          BG002
          value
          255
      title
      Western Europe
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          87
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          134
        3. group Id
          BG002
          value
          266
      title
      Rest of the World
    description
    Participants were categorized based on region western europe, US and rest of the world.
    param Type
    NUMBER
    title
    Region
    unit Of Measure
    participants
population Description
The full analysis set (FAS) consisted of all participants who were randomized.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      301
    2. group Id
      BG001
      value
      307
    3. group Id
      BG002
      value
      608
    units
    Participants
groups
  1. description
    Participants received 1.25 mg/kg of body weight enfortumab vedotin by IV infusion over approximately 30 minutes on days 1, 8 and 15 of every 28day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
    id
    BG000
    title
    Enfortumab Vedotin 1.25 mg/kg
  2. description
    Participants received either 75 mg/m\^2 docetaxel by IV infusion over approximately 1 hour or 320 mg/m\^2 vinflunine by IV infusion over approximately 20 minutes or 175 mg/m\^2 paclitaxel by IV infusion over approximately 3 hours on day 1 of every 21-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first.
    id
    BG001
    title
    Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.11
          value
          66.52
        2. group Id
          BG001
          spread
          9.93
          value
          66.81
        3. group Id
          BG002
          spread
          9.53
          value
          66.67
    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
          63
        2. group Id
          BG001
          value
          75
        3. group Id
          BG002
          value
          138
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          238
        2. group Id
          BG001
          value
          232
        3. group Id
          BG002
          value
          470
        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
          29
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          53
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          230
        2. group Id
          BG001
          value
          238
        3. group Id
          BG002
          value
          468
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          45
        3. group Id
          BG002
          value
          87
        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
          97
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          200
        title
        Asian
      3. 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
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          159
        2. group Id
          BG001
          value
          155
        3. group Id
          BG002
          value
          314
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          89
        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
          120
        2. group Id
          BG001
          value
          124
        3. group Id
          BG002
          value
          244
      title
      ECOG PS=0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          181
        2. group Id
          BG001
          value
          183
        3. group Id
          BG002
          value
          364
      title
      ECOG PS=1
    description
    ECOG PS was measured on 6 point scale 0-Fully active, able to carry on all pre-disease performance without restriction 1. Restricted in physically strenuous activity but ambulatory \& able to carry out work of a light or sedentary nature 2. Ambulatory \& capable of all self-care but unable to carry out any work activities.Up \& about more than 50% of waking hours 3. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours 4. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair 5. Dead Participants were categorized based on ECOG PS 0 or 1
    param Type
    NUMBER
    title
    ECOG PS
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          208
        2. group Id
          BG001
          value
          212
        3. group Id
          BG002
          value
          420
      title
      Liver Metastasis=No
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          93
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          188
      title
      Liver Metastasis=Yes
    description
    Participants were categorized based on liver metastasis (yes or no).
    param Type
    NUMBER
    title
    Liver Metastasis
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          126
        2. group Id
          BG001
          value
          129
        3. group Id
          BG002
          value
          255
      title
      Western Europe
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          87
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          134
        3. group Id
          BG002
          value
          266
      title
      Rest of the World
    description
    Participants were categorized based on region western europe, US and rest of the world.
    param Type
    NUMBER
    title
    Region
    unit Of Measure
    participants
population Description
The full analysis set (FAS) consisted of all participants who were randomized.

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Preserved source evidence · Not medical advice