Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03036098 · BASELINE

Baseline characteristics

Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer · Source last updated 2026-03-06

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
      349
    2. group Id
      BG001
      value
      357
    3. group Id
      BG002
      value
      304
    4. group Id
      BG003
      value
      304
    5. group Id
      BG004
      value
      1314
    units
    Participants
groups
  1. description
    Participants received Nivolumab 1 mg/kg plus Ipilimumab 3 mg/kg every three weeks (Q3W) for up to 4 doses followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Primary Study
    id
    BG000
    title
    Treatment 1
  2. description
    Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Primary Study
    id
    BG001
    title
    Treatment 2
  3. description
    Participants received Nivolumab 360 mg in combination with Standard of Care treatment every 3 weeks (Q3W) for up to 6 cycles followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Sub-study
    id
    BG002
    title
    Treatment 3
  4. description
    Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Sub-study
    id
    BG003
    title
    Treatment 4
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. 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
        5. group Id
          BG004
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          120
        2. group Id
          BG001
          value
          127
        3. group Id
          BG002
          value
          150
        4. group Id
          BG003
          value
          148
        5. group Id
          BG004
          value
          545
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          229
        2. group Id
          BG001
          value
          230
        3. group Id
          BG002
          value
          154
        4. group Id
          BG003
          value
          156
        5. group Id
          BG004
          value
          769
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          88
        3. group Id
          BG002
          value
          68
        4. group Id
          BG003
          value
          70
        5. group Id
          BG004
          value
          306
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          269
        2. group Id
          BG001
          value
          269
        3. group Id
          BG002
          value
          236
        4. group Id
          BG003
          value
          234
        5. group Id
          BG004
          value
          1008
        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
          24
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          33
        5. group Id
          BG004
          value
          113
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          158
        2. group Id
          BG001
          value
          151
        3. group Id
          BG002
          value
          118
        4. group Id
          BG003
          value
          119
        5. group Id
          BG004
          value
          546
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          167
        2. group Id
          BG001
          value
          188
        3. group Id
          BG002
          value
          148
        4. group Id
          BG003
          value
          152
        5. group Id
          BG004
          value
          655
        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
          253
        2. group Id
          BG001
          value
          232
        3. group Id
          BG002
          value
          211
        4. group Id
          BG003
          value
          225
        5. group Id
          BG004
          value
          921
      title
      White
    2. categories
      1. 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
        5. group Id
          BG004
          value
          4
      title
      Black Or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          6
      title
      American Indian Or Alaska Native
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          79
        2. group Id
          BG001
          value
          105
        3. group Id
          BG002
          value
          75
        4. group Id
          BG003
          value
          63
        5. group Id
          BG004
          value
          322
      title
      Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          60
      title
      Other
    6. 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
          0
        5. group Id
          BG004
          value
          1
      title
      Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      349
    2. group Id
      BG001
      value
      357
    3. group Id
      BG002
      value
      304
    4. group Id
      BG003
      value
      304
    5. group Id
      BG004
      value
      1314
    units
    Participants
groups
  1. description
    Participants received Nivolumab 1 mg/kg plus Ipilimumab 3 mg/kg every three weeks (Q3W) for up to 4 doses followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Primary Study
    id
    BG000
    title
    Treatment 1
  2. description
    Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Primary Study
    id
    BG001
    title
    Treatment 2
  3. description
    Participants received Nivolumab 360 mg in combination with Standard of Care treatment every 3 weeks (Q3W) for up to 6 cycles followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Sub-study
    id
    BG002
    title
    Treatment 3
  4. description
    Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Sub-study
    id
    BG003
    title
    Treatment 4
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. 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
        5. group Id
          BG004
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          120
        2. group Id
          BG001
          value
          127
        3. group Id
          BG002
          value
          150
        4. group Id
          BG003
          value
          148
        5. group Id
          BG004
          value
          545
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          229
        2. group Id
          BG001
          value
          230
        3. group Id
          BG002
          value
          154
        4. group Id
          BG003
          value
          156
        5. group Id
          BG004
          value
          769
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          88
        3. group Id
          BG002
          value
          68
        4. group Id
          BG003
          value
          70
        5. group Id
          BG004
          value
          306
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          269
        2. group Id
          BG001
          value
          269
        3. group Id
          BG002
          value
          236
        4. group Id
          BG003
          value
          234
        5. group Id
          BG004
          value
          1008
        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
          24
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          33
        5. group Id
          BG004
          value
          113
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          158
        2. group Id
          BG001
          value
          151
        3. group Id
          BG002
          value
          118
        4. group Id
          BG003
          value
          119
        5. group Id
          BG004
          value
          546
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          167
        2. group Id
          BG001
          value
          188
        3. group Id
          BG002
          value
          148
        4. group Id
          BG003
          value
          152
        5. group Id
          BG004
          value
          655
        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
          253
        2. group Id
          BG001
          value
          232
        3. group Id
          BG002
          value
          211
        4. group Id
          BG003
          value
          225
        5. group Id
          BG004
          value
          921
      title
      White
    2. categories
      1. 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
        5. group Id
          BG004
          value
          4
      title
      Black Or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          6
      title
      American Indian Or Alaska Native
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          79
        2. group Id
          BG001
          value
          105
        3. group Id
          BG002
          value
          75
        4. group Id
          BG003
          value
          63
        5. group Id
          BG004
          value
          322
      title
      Asian
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          13
        5. group Id
          BG004
          value
          60
      title
      Other
    6. 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
          0
        5. group Id
          BG004
          value
          1
      title
      Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants

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

Preserved source evidence · Not medical advice