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NCT03043872 · BASELINE

Baseline characteristics

Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN) · Source last updated 2026-07-16

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
      329
    2. group Id
      BG001
      value
      328
    3. group Id
      BG002
      value
      330
    4. group Id
      BG003
      value
      987
    units
    Participants
groups
  1. description
    During Chemotherapy: Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Post-Chemotherapy: Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
    id
    BG000
    title
    All Patients: D + T + EP
  2. description
    During Chemotherapy: Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Post-Chemotherapy: Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
    id
    BG001
    title
    All Patients: D + EP
  3. description
    For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
    id
    BG002
    title
    All Patients: EP
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          62
        title
        <50
      2. measurements
        1. group Id
          BG000
          value
          175
        2. group Id
          BG001
          value
          195
        3. group Id
          BG002
          value
          169
        4. group Id
          BG003
          value
          539
        title
        ≥50 to <65
      3. measurements
        1. group Id
          BG000
          value
          108
        2. group Id
          BG001
          value
          98
        3. group Id
          BG002
          value
          110
        4. group Id
          BG003
          value
          316
        title
        ≥65 to <75
      4. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          70
        title
        ≥75
      denoms
      1. counts
        1. group Id
          BG000
          value
          329
        2. group Id
          BG001
          value
          328
        3. group Id
          BG002
          value
          330
        4. group Id
          BG003
          value
          987
        units
        Participants
      title
      Al Patients
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          46
        title
        <50
      2. measurements
        1. group Id
          BG000
          value
          138
        2. group Id
          BG001
          value
          157
        3. group Id
          BG002
          value
          137
        4. group Id
          BG003
          value
          432
        title
        ≥50 to <65
      3. measurements
        1. group Id
          BG000
          value
          91
        2. group Id
          BG001
          value
          82
        3. group Id
          BG002
          value
          90
        4. group Id
          BG003
          value
          263
        title
        ≥65 to <75
      4. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          64
        title
        ≥75
      denoms
      1. counts
        1. group Id
          BG000
          value
          268
        2. group Id
          BG001
          value
          268
        3. group Id
          BG002
          value
          269
        4. group Id
          BG003
          value
          805
        units
        Participants
      title
      Global Cohort
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          16
        title
        <50
      2. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          33
        4. group Id
          BG003
          value
          112
        title
        ≥50 to <65
      3. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          53
        title
        ≥65 to <75
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          7
        title
        ≥75
      denoms
      1. counts
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          188
        units
        Participants
      title
      China Cohort
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline data is presented for all patients, as well as separately for the global and China cohorts.
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          86
        3. group Id
          BG002
          value
          95
        4. group Id
          BG003
          value
          255
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          255
        2. group Id
          BG001
          value
          242
        3. group Id
          BG002
          value
          235
        4. group Id
          BG003
          value
          732
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          329
        2. group Id
          BG001
          value
          328
        3. group Id
          BG002
          value
          330
        4. group Id
          BG003
          value
          987
        units
        Participants
      title
      All Patients
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          78
        3. group Id
          BG002
          value
          85
        4. group Id
          BG003
          value
          229
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          202
        2. group Id
          BG001
          value
          190
        3. group Id
          BG002
          value
          184
        4. group Id
          BG003
          value
          576
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          268
        2. group Id
          BG001
          value
          268
        3. group Id
          BG002
          value
          269
        4. group Id
          BG003
          value
          805
        units
        Participants
      title
      Global Cohort
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          27
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          161
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          188
        units
        Participants
      title
      China Cohort
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline data is presented for all patients, as well as separately for the global and China cohorts.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          23
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          321
        2. group Id
          BG001
          value
          315
        3. group Id
          BG002
          value
          322
        4. group Id
          BG003
          value
          958
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          329
        2. group Id
          BG001
          value
          328
        3. group Id
          BG002
          value
          330
        4. group Id
          BG003
          value
          987
        units
        Participants
      title
      All Patients
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          23
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          260
        2. group Id
          BG001
          value
          255
        3. group Id
          BG002
          value
          261
        4. group Id
          BG003
          value
          776
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          268
        2. group Id
          BG001
          value
          268
        3. group Id
          BG002
          value
          269
        4. group Id
          BG003
          value
          805
        units
        Participants
      title
      Global Cohort
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          188
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          188
        units
        Participants
      title
      China Cohort
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline data is presented for all patients, as well as separately for the global and China cohorts.
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          215
        2. group Id
          BG001
          value
          229
        3. group Id
          BG002
          value
          221
        4. group Id
          BG003
          value
          665
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          108
        2. group Id
          BG001
          value
          96
        3. group Id
          BG002
          value
          103
        4. group Id
          BG003
          value
          307
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          8
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          329
        2. group Id
          BG001
          value
          328
        3. group Id
          BG002
          value
          330
        4. group Id
          BG003
          value
          987
        units
        Participants
      title
      All Patients
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          215
        2. group Id
          BG001
          value
          229
        3. group Id
          BG002
          value
          221
        4. group Id
          BG003
          value
          665
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          42
        4. group Id
          BG003
          value
          125
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          8
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          268
        2. group Id
          BG001
          value
          268
        3. group Id
          BG002
          value
          269
        4. group Id
          BG003
          value
          805
        units
        Participants
      title
      Global Cohort
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          188
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          188
        units
        Participants
      title
      China Cohort
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline data is presented for all patients, as well as separately for the global and China cohorts.
    title
    Race
    unit Of Measure
    Participants
population Description
Baseline analysis was based on the global full analysis set (FAS) (all patients randomized prior to the end of global recruitment) plus the China FAS (all randomized patients in the China cohort). Patients included in both cohorts are not double-counted for the baseline analysis represented by 'All Patients'.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      329
    2. group Id
      BG001
      value
      328
    3. group Id
      BG002
      value
      330
    4. group Id
      BG003
      value
      987
    units
    Participants
groups
  1. description
    During Chemotherapy: Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Post-Chemotherapy: Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
    id
    BG000
    title
    All Patients: D + T + EP
  2. description
    During Chemotherapy: Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Post-Chemotherapy: Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
    id
    BG001
    title
    All Patients: D + EP
  3. description
    For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). An additional 2 doses of EP (at Weeks 12 and 15) could be given at the investigators' discretion if clinically indicated.
    id
    BG002
    title
    All Patients: EP
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          13
        3. group Id
          BG002
          value
          28
        4. group Id
          BG003
          value
          62
        title
        <50
      2. measurements
        1. group Id
          BG000
          value
          175
        2. group Id
          BG001
          value
          195
        3. group Id
          BG002
          value
          169
        4. group Id
          BG003
          value
          539
        title
        ≥50 to <65
      3. measurements
        1. group Id
          BG000
          value
          108
        2. group Id
          BG001
          value
          98
        3. group Id
          BG002
          value
          110
        4. group Id
          BG003
          value
          316
        title
        ≥65 to <75
      4. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          23
        4. group Id
          BG003
          value
          70
        title
        ≥75
      denoms
      1. counts
        1. group Id
          BG000
          value
          329
        2. group Id
          BG001
          value
          328
        3. group Id
          BG002
          value
          330
        4. group Id
          BG003
          value
          987
        units
        Participants
      title
      Al Patients
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          46
        title
        <50
      2. measurements
        1. group Id
          BG000
          value
          138
        2. group Id
          BG001
          value
          157
        3. group Id
          BG002
          value
          137
        4. group Id
          BG003
          value
          432
        title
        ≥50 to <65
      3. measurements
        1. group Id
          BG000
          value
          91
        2. group Id
          BG001
          value
          82
        3. group Id
          BG002
          value
          90
        4. group Id
          BG003
          value
          263
        title
        ≥65 to <75
      4. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          64
        title
        ≥75
      denoms
      1. counts
        1. group Id
          BG000
          value
          268
        2. group Id
          BG001
          value
          268
        3. group Id
          BG002
          value
          269
        4. group Id
          BG003
          value
          805
        units
        Participants
      title
      Global Cohort
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          16
        title
        <50
      2. measurements
        1. group Id
          BG000
          value
          40
        2. group Id
          BG001
          value
          39
        3. group Id
          BG002
          value
          33
        4. group Id
          BG003
          value
          112
        title
        ≥50 to <65
      3. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          53
        title
        ≥65 to <75
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          7
        title
        ≥75
      denoms
      1. counts
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          188
        units
        Participants
      title
      China Cohort
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline data is presented for all patients, as well as separately for the global and China cohorts.
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          86
        3. group Id
          BG002
          value
          95
        4. group Id
          BG003
          value
          255
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          255
        2. group Id
          BG001
          value
          242
        3. group Id
          BG002
          value
          235
        4. group Id
          BG003
          value
          732
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          329
        2. group Id
          BG001
          value
          328
        3. group Id
          BG002
          value
          330
        4. group Id
          BG003
          value
          987
        units
        Participants
      title
      All Patients
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          78
        3. group Id
          BG002
          value
          85
        4. group Id
          BG003
          value
          229
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          202
        2. group Id
          BG001
          value
          190
        3. group Id
          BG002
          value
          184
        4. group Id
          BG003
          value
          576
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          268
        2. group Id
          BG001
          value
          268
        3. group Id
          BG002
          value
          269
        4. group Id
          BG003
          value
          805
        units
        Participants
      title
      Global Cohort
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          27
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          57
        2. group Id
          BG001
          value
          52
        3. group Id
          BG002
          value
          52
        4. group Id
          BG003
          value
          161
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          188
        units
        Participants
      title
      China Cohort
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline data is presented for all patients, as well as separately for the global and China cohorts.
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          23
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          321
        2. group Id
          BG001
          value
          315
        3. group Id
          BG002
          value
          322
        4. group Id
          BG003
          value
          958
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          329
        2. group Id
          BG001
          value
          328
        3. group Id
          BG002
          value
          330
        4. group Id
          BG003
          value
          987
        units
        Participants
      title
      All Patients
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          6
        4. group Id
          BG003
          value
          23
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          260
        2. group Id
          BG001
          value
          255
        3. group Id
          BG002
          value
          261
        4. group Id
          BG003
          value
          776
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          6
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          268
        2. group Id
          BG001
          value
          268
        3. group Id
          BG002
          value
          269
        4. group Id
          BG003
          value
          805
        units
        Participants
      title
      Global Cohort
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          188
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          188
        units
        Participants
      title
      China Cohort
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline data is presented for all patients, as well as separately for the global and China cohorts.
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          215
        2. group Id
          BG001
          value
          229
        3. group Id
          BG002
          value
          221
        4. group Id
          BG003
          value
          665
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          108
        2. group Id
          BG001
          value
          96
        3. group Id
          BG002
          value
          103
        4. group Id
          BG003
          value
          307
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          8
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          329
        2. group Id
          BG001
          value
          328
        3. group Id
          BG002
          value
          330
        4. group Id
          BG003
          value
          987
        units
        Participants
      title
      All Patients
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          215
        2. group Id
          BG001
          value
          229
        3. group Id
          BG002
          value
          221
        4. group Id
          BG003
          value
          665
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          6
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          47
        2. group Id
          BG001
          value
          36
        3. group Id
          BG002
          value
          42
        4. group Id
          BG003
          value
          125
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          8
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          1
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          268
        2. group Id
          BG001
          value
          268
        3. group Id
          BG002
          value
          269
        4. group Id
          BG003
          value
          805
        units
        Participants
      title
      Global Cohort
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        White
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          188
        title
        Asian
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          65
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          62
        4. group Id
          BG003
          value
          188
        units
        Participants
      title
      China Cohort
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Baseline data is presented for all patients, as well as separately for the global and China cohorts.
    title
    Race
    unit Of Measure
    Participants
population Description
Baseline analysis was based on the global full analysis set (FAS) (all patients randomized prior to the end of global recruitment) plus the China FAS (all randomized patients in the China cohort). Patients included in both cohorts are not double-counted for the baseline analysis represented by 'All Patients'.

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