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NCT02516241 · BASELINE

Baseline characteristics

Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer · Source last updated 2026-07-14

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
      342
    2. group Id
      BG001
      value
      346
    3. group Id
      BG002
      value
      344
    4. group Id
      BG003
      value
      1032
    units
    Participants
groups
  1. description
    MEDI4736 (Durvalumab) + Tremelimumab
    id
    BG000
    title
    Combination Therapy
  2. description
    MEDI4736 (Durvalumab)
    id
    BG001
    title
    Monotherapy
  3. description
    Standard of Care Chemotherapy Treatment
    id
    BG002
    title
    Standard of Care
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.60
          value
          66.4
        2. group Id
          BG001
          spread
          9.9
          value
          66.3
        3. group Id
          BG002
          spread
          9.32
          value
          67.0
        4. group Id
          BG003
          spread
          9.60
          value
          66.5
      title
      Age (years)
    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
          19
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          55
        title
        <50
      2. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          115
        3. group Id
          BG002
          value
          119
        4. group Id
          BG003
          value
          352
        title
        >= 50 - < 65
      3. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          141
        3. group Id
          BG002
          value
          137
        4. group Id
          BG003
          value
          410
        title
        >= 65 - < 75
      4. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          74
        4. group Id
          BG003
          value
          215
        title
        >= 75
      title
      Age Group (Years)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          86
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          70
        4. group Id
          BG003
          value
          253
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          256
        2. group Id
          BG001
          value
          249
        3. group Id
          BG002
          value
          274
        4. group Id
          BG003
          value
          779
        title
        Male
      title
      Sex
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          46
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          320
        2. group Id
          BG001
          value
          329
        3. group Id
          BG002
          value
          322
        4. group Id
          BG003
          value
          971
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          15
        title
        Unknown or Not Reported
      title
      Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          253
        2. group Id
          BG001
          value
          278
        3. group Id
          BG002
          value
          260
        4. group Id
          BG003
          value
          791
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          6
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          72
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          76
        4. group Id
          BG003
          value
          208
        title
        Asian
      4. 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
      5. 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
      6. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          25
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Unknown or Not Reported
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      342
    2. group Id
      BG001
      value
      346
    3. group Id
      BG002
      value
      344
    4. group Id
      BG003
      value
      1032
    units
    Participants
groups
  1. description
    MEDI4736 (Durvalumab) + Tremelimumab
    id
    BG000
    title
    Combination Therapy
  2. description
    MEDI4736 (Durvalumab)
    id
    BG001
    title
    Monotherapy
  3. description
    Standard of Care Chemotherapy Treatment
    id
    BG002
    title
    Standard of Care
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.60
          value
          66.4
        2. group Id
          BG001
          spread
          9.9
          value
          66.3
        3. group Id
          BG002
          spread
          9.32
          value
          67.0
        4. group Id
          BG003
          spread
          9.60
          value
          66.5
      title
      Age (years)
    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
          19
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          55
        title
        <50
      2. measurements
        1. group Id
          BG000
          value
          118
        2. group Id
          BG001
          value
          115
        3. group Id
          BG002
          value
          119
        4. group Id
          BG003
          value
          352
        title
        >= 50 - < 65
      3. measurements
        1. group Id
          BG000
          value
          132
        2. group Id
          BG001
          value
          141
        3. group Id
          BG002
          value
          137
        4. group Id
          BG003
          value
          410
        title
        >= 65 - < 75
      4. measurements
        1. group Id
          BG000
          value
          73
        2. group Id
          BG001
          value
          68
        3. group Id
          BG002
          value
          74
        4. group Id
          BG003
          value
          215
        title
        >= 75
      title
      Age Group (Years)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          86
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          70
        4. group Id
          BG003
          value
          253
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          256
        2. group Id
          BG001
          value
          249
        3. group Id
          BG002
          value
          274
        4. group Id
          BG003
          value
          779
        title
        Male
      title
      Sex
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          46
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          320
        2. group Id
          BG001
          value
          329
        3. group Id
          BG002
          value
          322
        4. group Id
          BG003
          value
          971
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          5
        4. group Id
          BG003
          value
          15
        title
        Unknown or Not Reported
      title
      Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          253
        2. group Id
          BG001
          value
          278
        3. group Id
          BG002
          value
          260
        4. group Id
          BG003
          value
          791
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          6
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          72
        2. group Id
          BG001
          value
          60
        3. group Id
          BG002
          value
          76
        4. group Id
          BG003
          value
          208
        title
        Asian
      4. 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
      5. 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
      6. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          25
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Unknown or Not Reported
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Full analysis set (FAS) included all randomized participants analyzed on an intent-to-treat (ITT) basis.

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Preserved source evidence · Not medical advice