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NCT02125461 · BASELINE

Baseline characteristics

A Global Study to Assess the Effects of MEDI4736 Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer · Source last updated 2023-10-10

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
      476
    2. group Id
      BG001
      value
      237
    3. group Id
      BG002
      value
      713
    units
    Participants
groups
  1. description
    Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.
    id
    BG000
    title
    Durvalumab (MEDI4736)
  2. description
    Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.66
          value
          63.0
        2. group Id
          BG001
          spread
          9.64
          value
          62.6
        3. group Id
          BG002
          spread
          8.99
          value
          62.9
    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
          142
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          213
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          334
        2. group Id
          BG001
          value
          166
        3. group Id
          BG002
          value
          500
        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
          337
        2. group Id
          BG001
          value
          157
        3. group Id
          BG002
          value
          494
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          14
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          120
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          192
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Native Hawaiian or Pacific Islander
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          9
      title
      American Indian or Alaska Native
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Other
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          64
        title
        Non-smoker
      2. measurements
        1. group Id
          BG000
          value
          354
        2. group Id
          BG001
          value
          178
        3. group Id
          BG002
          value
          532
        title
        Ex-smoker
      3. measurements
        1. group Id
          BG000
          value
          79
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          117
        title
        Current smoker
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Smoking History
    unit Of Measure
    Participants
population Description
Baseline analysis was based on the FAS consisting of all randomized patients.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      476
    2. group Id
      BG001
      value
      237
    3. group Id
      BG002
      value
      713
    units
    Participants
groups
  1. description
    Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.
    id
    BG000
    title
    Durvalumab (MEDI4736)
  2. description
    Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.
    id
    BG001
    title
    Placebo
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.66
          value
          63.0
        2. group Id
          BG001
          spread
          9.64
          value
          62.6
        3. group Id
          BG002
          spread
          8.99
          value
          62.9
    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
          142
        2. group Id
          BG001
          value
          71
        3. group Id
          BG002
          value
          213
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          334
        2. group Id
          BG001
          value
          166
        3. group Id
          BG002
          value
          500
        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
          337
        2. group Id
          BG001
          value
          157
        3. group Id
          BG002
          value
          494
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          14
      title
      Black or African American
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          120
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          192
      title
      Asian
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
      title
      Native Hawaiian or Pacific Islander
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          9
      title
      American Indian or Alaska Native
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Other
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      Missing
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          64
        title
        Non-smoker
      2. measurements
        1. group Id
          BG000
          value
          354
        2. group Id
          BG001
          value
          178
        3. group Id
          BG002
          value
          532
        title
        Ex-smoker
      3. measurements
        1. group Id
          BG000
          value
          79
        2. group Id
          BG001
          value
          38
        3. group Id
          BG002
          value
          117
        title
        Current smoker
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Smoking History
    unit Of Measure
    Participants
population Description
Baseline analysis was based on the FAS consisting of all randomized patients.

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Preserved source evidence · Not medical advice