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NCT03875235 · BASELINE

Baseline characteristics

Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1) · Source last updated 2026-08-26

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
      341
    2. group Id
      BG001
      value
      344
    3. group Id
      BG002
      value
      685
    units
    Participants
groups
  1. description
    Drug: Durvalumab IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
    id
    BG000
    title
    Durvalumab + Gemcitabine + Cisplatin
  2. description
    Drug: Placebo IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
    id
    BG001
    title
    Placebo + 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
          10.49
          value
          62.2
        2. group Id
          BG001
          spread
          10.66
          value
          62.6
        3. group Id
          BG002
          spread
          10.57
          value
          62.4
    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
          181
        2. group Id
          BG001
          value
          184
        3. group Id
          BG002
          value
          365
        title
        < 65 years
      2. measurements
        1. group Id
          BG000
          value
          122
        2. group Id
          BG001
          value
          114
        3. group Id
          BG002
          value
          236
        title
        >=65 - < 75 years
      3. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          84
        title
        >= 75 years
      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
          172
        2. group Id
          BG001
          value
          168
        3. group Id
          BG002
          value
          340
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          169
        2. group Id
          BG001
          value
          176
        3. group Id
          BG002
          value
          345
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        American Indian of Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          185
        2. group Id
          BG001
          value
          201
        3. group Id
          BG002
          value
          386
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          14
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          131
        2. group Id
          BG001
          value
          124
        3. group Id
          BG002
          value
          255
        title
        White
      5. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          29
        title
        Other
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Baseline analysis was based on all patients in the full analysis set (FAS), which comprised all patients randomized prior to or on 18 December 2020. Patients were included in the analysis in the treatment arm to which they were randomized, regardless of the treatment they received.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      341
    2. group Id
      BG001
      value
      344
    3. group Id
      BG002
      value
      685
    units
    Participants
groups
  1. description
    Drug: Durvalumab IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
    id
    BG000
    title
    Durvalumab + Gemcitabine + Cisplatin
  2. description
    Drug: Placebo IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
    id
    BG001
    title
    Placebo + 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
          10.49
          value
          62.2
        2. group Id
          BG001
          spread
          10.66
          value
          62.6
        3. group Id
          BG002
          spread
          10.57
          value
          62.4
    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
          181
        2. group Id
          BG001
          value
          184
        3. group Id
          BG002
          value
          365
        title
        < 65 years
      2. measurements
        1. group Id
          BG000
          value
          122
        2. group Id
          BG001
          value
          114
        3. group Id
          BG002
          value
          236
        title
        >=65 - < 75 years
      3. measurements
        1. group Id
          BG000
          value
          38
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          84
        title
        >= 75 years
      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
          172
        2. group Id
          BG001
          value
          168
        3. group Id
          BG002
          value
          340
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          169
        2. group Id
          BG001
          value
          176
        3. group Id
          BG002
          value
          345
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        American Indian of Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          185
        2. group Id
          BG001
          value
          201
        3. group Id
          BG002
          value
          386
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          14
        title
        Black or African American
      4. measurements
        1. group Id
          BG000
          value
          131
        2. group Id
          BG001
          value
          124
        3. group Id
          BG002
          value
          255
        title
        White
      5. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          29
        title
        Other
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Baseline analysis was based on all patients in the full analysis set (FAS), which comprised all patients randomized prior to or on 18 December 2020. Patients were included in the analysis in the treatment arm to which they were randomized, regardless of the treatment they received.

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

Preserved source evidence · Not medical advice