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NCT05243550 · BASELINE

Baseline characteristics

A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer · Source last updated 2026-05-11

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
      240
    units
    Participants
groups
  1. description
    6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
    id
    BG000
    title
    UGN-102
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          78
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          162
        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
          lower Limit
          30
          upper Limit
          92
          value
          70
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          93
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          147
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          237
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          234
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          85
      title
      Bulgaria
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          41
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          38
      title
      Latvia
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      Georgia
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      title
      Serbia
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      Estonia
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Spain
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Lithuania
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Poland
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Austria
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          229
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          11
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Previous Low-grade Non-muscle Invasive Bladder Cancer (LG-NMIBC) Episode(s)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          124
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          116
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Previous LG-NMIBC Episode(s) Within 1 Year
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          228
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          12
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Transurethral Resection of Bladder Tumor (TURBT) to Treat LG-NMIBC
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          216
        title
        ≤ 3 cm
      2. measurements
        1. group Id
          BG000
          value
          19
        title
        > 3 cm
      3. measurements
        1. group Id
          BG000
          value
          5
        title
        Missing
    description
    Longest tumor diameter is defined as the longest diameter among all measurable lesions.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Longest Tumor Diameter
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          180
        title
        ≤ 3 cm
      2. measurements
        1. group Id
          BG000
          value
          41
        title
        > 3 cm
      3. measurements
        1. group Id
          BG000
          value
          19
        title
        Missing
    description
    Tumor burden is defined as the sum of the longest diameters of measurable lesions.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Tumor Burden
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        title
        Single
      2. measurements
        1. group Id
          BG000
          value
          198
        title
        Multiple
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Tumor Count
    unit Of Measure
    Participants
population Description
All patients who received any dose of UGN-102.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      240
    units
    Participants
groups
  1. description
    6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
    id
    BG000
    title
    UGN-102
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          78
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          162
        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
          lower Limit
          30
          upper Limit
          92
          value
          70
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          93
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          147
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          237
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          234
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          85
      title
      Bulgaria
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          41
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          38
      title
      Latvia
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          20
      title
      Georgia
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          18
      title
      Serbia
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      Estonia
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          8
      title
      Spain
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Lithuania
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Poland
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          2
      title
      Austria
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          229
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          11
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Previous Low-grade Non-muscle Invasive Bladder Cancer (LG-NMIBC) Episode(s)
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          124
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          116
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Previous LG-NMIBC Episode(s) Within 1 Year
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          228
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          12
        title
        No
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Prior Transurethral Resection of Bladder Tumor (TURBT) to Treat LG-NMIBC
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          216
        title
        ≤ 3 cm
      2. measurements
        1. group Id
          BG000
          value
          19
        title
        > 3 cm
      3. measurements
        1. group Id
          BG000
          value
          5
        title
        Missing
    description
    Longest tumor diameter is defined as the longest diameter among all measurable lesions.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Longest Tumor Diameter
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          180
        title
        ≤ 3 cm
      2. measurements
        1. group Id
          BG000
          value
          41
        title
        > 3 cm
      3. measurements
        1. group Id
          BG000
          value
          19
        title
        Missing
    description
    Tumor burden is defined as the sum of the longest diameters of measurable lesions.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Tumor Burden
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          41
        title
        Single
      2. measurements
        1. group Id
          BG000
          value
          198
        title
        Multiple
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Tumor Count
    unit Of Measure
    Participants
population Description
All patients who received any dose of UGN-102.

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Preserved source evidence · Not medical advice