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NCT03430843 · BASELINE

Baseline characteristics

A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma · Source last updated 2024-10-26

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
      256
    2. group Id
      BG001
      value
      256
    3. group Id
      BG002
      value
      512
    units
    Participants
groups
  1. description
    Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
    id
    BG000
    title
    Tislelizumab
  2. description
    Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
    id
    BG001
    title
    Investigator Chosen Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.41
          value
          61.8
        2. group Id
          BG001
          spread
          8.02
          value
          61.8
        3. group Id
          BG002
          spread
          8.21
          value
          61.8
    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
          39
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          80
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          217
        2. group Id
          BG001
          value
          215
        3. group Id
          BG002
          value
          432
        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
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          252
        2. group Id
          BG001
          value
          252
        3. group Id
          BG002
          value
          504
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        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
          201
        2. group Id
          BG001
          value
          207
        3. group Id
          BG002
          value
          408
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          97
        title
        White or Caucasian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Not Reported
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Unknown
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Other
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          127
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          190
        2. group Id
          BG001
          value
          195
        3. group Id
          BG002
          value
          385
        title
        1
    description
    Measure Description: ECOG performance status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status Score
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          142
        title
        vCPS >= 10%
      2. measurements
        1. group Id
          BG000
          value
          100
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          222
        title
        vCPS < 10%
      3. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          148
        title
        Missing
    description
    Measure Description: Programmed death ligand 1 (PD-L1) positive is defined as visually-estimated Combined Positive Score (vCPS) \>= 10%, PD-L1 negative is defined as vCPS \< 10%, PD-L1 missing refers to the participants without sample collection, not evaluable at baseline, or scored with unqualified sample. Note terminology was updated from vCPS to Tumor Area Positivity (TAP) score in manuscripts.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PD-L1 Expression Status
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      256
    2. group Id
      BG001
      value
      256
    3. group Id
      BG002
      value
      512
    units
    Participants
groups
  1. description
    Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
    id
    BG000
    title
    Tislelizumab
  2. description
    Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
    id
    BG001
    title
    Investigator Chosen Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.41
          value
          61.8
        2. group Id
          BG001
          spread
          8.02
          value
          61.8
        3. group Id
          BG002
          spread
          8.21
          value
          61.8
    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
          39
        2. group Id
          BG001
          value
          41
        3. group Id
          BG002
          value
          80
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          217
        2. group Id
          BG001
          value
          215
        3. group Id
          BG002
          value
          432
        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
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          252
        2. group Id
          BG001
          value
          252
        3. group Id
          BG002
          value
          504
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        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
          201
        2. group Id
          BG001
          value
          207
        3. group Id
          BG002
          value
          408
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          53
        2. group Id
          BG001
          value
          44
        3. group Id
          BG002
          value
          97
        title
        White or Caucasian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Not Reported
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        Unknown
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        title
        Black or African American
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Other
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          66
        2. group Id
          BG001
          value
          61
        3. group Id
          BG002
          value
          127
        title
        0
      2. measurements
        1. group Id
          BG000
          value
          190
        2. group Id
          BG001
          value
          195
        3. group Id
          BG002
          value
          385
        title
        1
    description
    Measure Description: ECOG performance status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity)
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status Score
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          80
        2. group Id
          BG001
          value
          62
        3. group Id
          BG002
          value
          142
        title
        vCPS >= 10%
      2. measurements
        1. group Id
          BG000
          value
          100
        2. group Id
          BG001
          value
          122
        3. group Id
          BG002
          value
          222
        title
        vCPS < 10%
      3. measurements
        1. group Id
          BG000
          value
          76
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          148
        title
        Missing
    description
    Measure Description: Programmed death ligand 1 (PD-L1) positive is defined as visually-estimated Combined Positive Score (vCPS) \>= 10%, PD-L1 negative is defined as vCPS \< 10%, PD-L1 missing refers to the participants without sample collection, not evaluable at baseline, or scored with unqualified sample. Note terminology was updated from vCPS to Tumor Area Positivity (TAP) score in manuscripts.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    PD-L1 Expression Status
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice