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NCT03732677 · BASELINE

Baseline characteristics

Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC · Source last updated 2026-07-17

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
      533
    2. group Id
      BG001
      value
      530
    3. group Id
      BG002
      value
      1063
    units
    Participants
groups
  1. description
    Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
    id
    BG000
    title
    Durvalumab + Gemcitabine + Cisplatin
  2. description
    Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
    id
    BG001
    title
    Gemcitabine + Cisplatin
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.9
          value
          64.1
        2. group Id
          BG001
          spread
          8.9
          value
          64.6
        3. group Id
          BG002
          spread
          8.9
          value
          64.4
    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
          96
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          193
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          437
        2. group Id
          BG001
          value
          433
        3. group Id
          BG002
          value
          870
        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
          44
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          85
      title
      HISPANIC OR LATINO
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          18
      title
      MISSING
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          483
        2. group Id
          BG001
          value
          477
        3. group Id
          BG002
          value
          960
      title
      NOT HISPANIC OR LATINO
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          152
        2. group Id
          BG001
          value
          145
        3. group Id
          BG002
          value
          297
      title
      ASIAN
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
      title
      BLACK OR AFRICAN AMERICAN
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          36
      title
      MISSING
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          8
      title
      OTHER
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          354
        2. group Id
          BG001
          value
          358
        3. group Id
          BG002
          value
          712
      title
      WHITE
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The Full analysis set (FAS) included all randomized participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      533
    2. group Id
      BG001
      value
      530
    3. group Id
      BG002
      value
      1063
    units
    Participants
groups
  1. description
    Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
    id
    BG000
    title
    Durvalumab + Gemcitabine + Cisplatin
  2. description
    Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
    id
    BG001
    title
    Gemcitabine + Cisplatin
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.9
          value
          64.1
        2. group Id
          BG001
          spread
          8.9
          value
          64.6
        3. group Id
          BG002
          spread
          8.9
          value
          64.4
    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
          96
        2. group Id
          BG001
          value
          97
        3. group Id
          BG002
          value
          193
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          437
        2. group Id
          BG001
          value
          433
        3. group Id
          BG002
          value
          870
        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
          44
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          85
      title
      HISPANIC OR LATINO
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          18
      title
      MISSING
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          483
        2. group Id
          BG001
          value
          477
        3. group Id
          BG002
          value
          960
      title
      NOT HISPANIC OR LATINO
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          152
        2. group Id
          BG001
          value
          145
        3. group Id
          BG002
          value
          297
      title
      ASIAN
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          10
      title
      BLACK OR AFRICAN AMERICAN
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          36
      title
      MISSING
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          8
      title
      OTHER
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          354
        2. group Id
          BG001
          value
          358
        3. group Id
          BG002
          value
          712
      title
      WHITE
    param Type
    NUMBER
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
The Full analysis set (FAS) included all randomized participants.

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

Preserved source evidence · Not medical advice