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NCT02773849 · BASELINE

Baseline characteristics

ADSTILADRIN (=INSTILADRIN) in Patients With High-Grade, Bacillus Calmette-Guerin (BCG) Unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) · Source last updated 2024-07-29

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
      107
    2. group Id
      BG001
      value
      50
    3. group Id
      BG002
      value
      157
    units
    Participants
groups
  1. description
    Patients with Carcinoma in situ (CIS) with or without concomitant high-grade Ta or T1 papillary disease
    id
    BG000
    title
    Carcinoma in Situ
  2. description
    Patients with high-grade Ta or T1 papillary disease (without concomitant CIS)
    id
    BG001
    title
    Papillary Disease
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          38
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          82
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          119
        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
          12
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          28
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          95
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          129
        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
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          148
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
        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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          146
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          107
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          157
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.8
          value
          174.7
        2. group Id
          BG001
          spread
          10.3
          value
          170.9
        3. group Id
          BG002
          spread
          10.1
          value
          173.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    cm
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          20.9
          value
          90.14
        2. group Id
          BG001
          spread
          18.6
          value
          85.88
        3. group Id
          BG002
          spread
          20.2
          value
          88.78
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.7
          value
          29.38
        2. group Id
          BG001
          spread
          5.1
          value
          29.28
        3. group Id
          BG002
          spread
          5.5
          value
          29.34
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Mass Index
    unit Of Measure
    kg/m^2
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          97
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          140
      title
      Total ECOG of 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          13
      title
      Total ECOG of 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
      title
      Total ECOG of 2
    description
    The ECOG performance status was assessed according to a scale from 0 to 5, where 0 is fully active, able to carry on all pre-disease performance without restriction and where 4 is completely disabled, cannot carry on any self-care, totally confined to bed or chair and 5 is dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Status
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      107
    2. group Id
      BG001
      value
      50
    3. group Id
      BG002
      value
      157
    units
    Participants
groups
  1. description
    Patients with Carcinoma in situ (CIS) with or without concomitant high-grade Ta or T1 papillary disease
    id
    BG000
    title
    Carcinoma in Situ
  2. description
    Patients with high-grade Ta or T1 papillary disease (without concomitant CIS)
    id
    BG001
    title
    Papillary Disease
  3. description
    Total of all reporting groups
    id
    BG002
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          38
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          82
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          119
        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
          12
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          28
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          95
        2. group Id
          BG001
          value
          34
        3. group Id
          BG002
          value
          129
        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
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          49
        3. group Id
          BG002
          value
          148
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          5
        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
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          47
        3. group Id
          BG002
          value
          146
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          107
        2. group Id
          BG001
          value
          50
        3. group Id
          BG002
          value
          157
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.8
          value
          174.7
        2. group Id
          BG001
          spread
          10.3
          value
          170.9
        3. group Id
          BG002
          spread
          10.1
          value
          173.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    cm
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          20.9
          value
          90.14
        2. group Id
          BG001
          spread
          18.6
          value
          85.88
        3. group Id
          BG002
          spread
          20.2
          value
          88.78
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          5.7
          value
          29.38
        2. group Id
          BG001
          spread
          5.1
          value
          29.28
        3. group Id
          BG002
          spread
          5.5
          value
          29.34
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Mass Index
    unit Of Measure
    kg/m^2
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          97
        2. group Id
          BG001
          value
          43
        3. group Id
          BG002
          value
          140
      title
      Total ECOG of 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          13
      title
      Total ECOG of 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          4
      title
      Total ECOG of 2
    description
    The ECOG performance status was assessed according to a scale from 0 to 5, where 0 is fully active, able to carry on all pre-disease performance without restriction and where 4 is completely disabled, cannot carry on any self-care, totally confined to bed or chair and 5 is dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG Status
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice