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NCT03261947 · BASELINE

Baseline characteristics

A Study to Evaluate the Safety, Tolerability, and Activity of TAK-931 in Participants With Metastatic Pancreatic Cancer, Metastatic Colorectal Cancer, and Other Advanced Solid Tumors · Source last updated 2021-09-20

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
      12
    2. group Id
      BG001
      value
      15
    3. group Id
      BG002
      value
      35
    4. group Id
      BG003
      value
      21
    5. group Id
      BG004
      value
      18
    6. group Id
      BG005
      value
      101
    units
    Participants
groups
  1. description
    TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.
    id
    BG000
    title
    Western Safety Cohort
  2. description
    TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
    id
    BG001
    title
    Pancreatic Cancer Cohort
  3. description
    TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.
    id
    BG002
    title
    Metastatic CRC Cohort
  4. description
    TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
    id
    BG003
    title
    sqEC Cohort
  5. description
    TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
    id
    BG004
    title
    sqNSCLC Cohort
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.16
          value
          59.3
        2. group Id
          BG001
          spread
          12.27
          value
          63.1
        3. group Id
          BG002
          spread
          11.93
          value
          58.3
        4. group Id
          BG003
          spread
          7.71
          value
          64.2
        5. group Id
          BG004
          spread
          7.74
          value
          64.4
        6. group Id
          BG005
          spread
          10.23
          value
          61.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          101
        units
        Participants
    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
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          40
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          11
        6. group Id
          BG005
          value
          61
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          101
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          34
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          96
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          101
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          29
        title
        Asian
      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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          15
        6. group Id
          BG005
          value
          64
        title
        White
      6. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        More than one race
      7. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          101
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          29
      denoms
      1. counts
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          101
        units
        Participants
      title
      Japan
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          72
      denoms
      1. counts
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          101
        units
        Participants
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.371
          value
          172.47
        2. group Id
          BG001
          spread
          11.596
          value
          170.61
        3. group Id
          BG002
          spread
          10.203
          value
          168.64
        4. group Id
          BG003
          spread
          7.975
          value
          167.11
        5. group Id
          BG004
          spread
          10.693
          value
          172.26
        6. group Id
          BG005
          spread
          10.513
          value
          169.75
      denoms
      1. counts
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          34
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          99
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Number analyzed is the number of participants with data available for height at the Baseline.
    title
    Height
    unit Of Measure
    cm
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          16.052
          value
          79.33
        2. group Id
          BG001
          spread
          22.763
          value
          73.22
        3. group Id
          BG002
          spread
          17.457
          value
          79.90
        4. group Id
          BG003
          spread
          10.358
          value
          57.07
        5. group Id
          BG004
          spread
          18.770
          value
          77.70
        6. group Id
          BG005
          spread
          19.076
          value
          73.87
      denoms
      1. counts
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          100
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Number analyzed is the number of participants with data available for weight at the Baseline.
    title
    Weight
    unit Of Measure
    kg
  8. classes
    1. 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
          12
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          15
        title
        Tobacco
      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
          6
        5. group Id
          BG004
          value
          15
        6. group Id
          BG005
          value
          21
        title
        Cigarette
      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
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        title
        Cigar
      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
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        title
        Pipe
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          38
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Data for substance use was collected only for sqEC and sqNSCLC cohorts. Number analyzed is the number of participants with data available for substance use at Baseline.
    title
    Substance Use
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          65
        title
        Never Smoked
      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
          3
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          10
        title
        Current Smoker
      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
          16
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          26
        title
        Former Smoker
      denoms
      1. counts
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          101
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Smoking Classification
    unit Of Measure
    Participants
population Description
Safety Analysis Set included all participants who received any amount of study drug.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      12
    2. group Id
      BG001
      value
      15
    3. group Id
      BG002
      value
      35
    4. group Id
      BG003
      value
      21
    5. group Id
      BG004
      value
      18
    6. group Id
      BG005
      value
      101
    units
    Participants
groups
  1. description
    TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, once daily (QD) for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 20 cycles. Participants with locally advanced or metastatic solid tumors with no standard therapeutic alternative in the United States were included in this cohort.
    id
    BG000
    title
    Western Safety Cohort
  2. description
    TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 4 cycles. Participants with metastatic pancreatic cancer who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
    id
    BG001
    title
    Pancreatic Cancer Cohort
  3. description
    TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 12 cycles. Participants with metastatic CRC who had progressed after at least 2 lines of previous standard chemotherapy were included in this cohort.
    id
    BG002
    title
    Metastatic CRC Cohort
  4. description
    TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 8 cycles. Participants with metastatic sqEC who had progressed after at least 1 line of standard chemotherapy were included in this cohort.
    id
    BG003
    title
    sqEC Cohort
  5. description
    TAK-931 50 mg (2x25 mg or 5x10 mg), capsules, orally, QD for 14 days, followed by a 7-day washout period (14 days on and 7 days off study drug), in 21-day cycles until disease progression or unacceptable treatment-related toxicity up to 18 cycles. Participants with metastatic sqNSCLC who had progressed after at least 2 lines of standard treatment were included in this cohort.
    id
    BG004
    title
    sqNSCLC Cohort
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.16
          value
          59.3
        2. group Id
          BG001
          spread
          12.27
          value
          63.1
        3. group Id
          BG002
          spread
          11.93
          value
          58.3
        4. group Id
          BG003
          spread
          7.71
          value
          64.2
        5. group Id
          BG004
          spread
          7.74
          value
          64.4
        6. group Id
          BG005
          spread
          10.23
          value
          61.5
      denoms
      1. counts
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          101
        units
        Participants
    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
          5
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          40
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          16
        4. group Id
          BG003
          value
          17
        5. group Id
          BG004
          value
          11
        6. group Id
          BG005
          value
          61
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          101
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          34
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          96
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          3
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          101
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          29
        title
        Asian
      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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          8
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          24
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          15
        6. group Id
          BG005
          value
          64
        title
        White
      6. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        More than one race
      7. 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
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          101
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          16
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          29
      denoms
      1. counts
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          101
        units
        Participants
      title
      Japan
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          5
        5. group Id
          BG004
          value
          16
        6. group Id
          BG005
          value
          72
      denoms
      1. counts
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          101
        units
        Participants
      title
      United States
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.371
          value
          172.47
        2. group Id
          BG001
          spread
          11.596
          value
          170.61
        3. group Id
          BG002
          spread
          10.203
          value
          168.64
        4. group Id
          BG003
          spread
          7.975
          value
          167.11
        5. group Id
          BG004
          spread
          10.693
          value
          172.26
        6. group Id
          BG005
          spread
          10.513
          value
          169.75
      denoms
      1. counts
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          34
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          99
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Number analyzed is the number of participants with data available for height at the Baseline.
    title
    Height
    unit Of Measure
    cm
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          16.052
          value
          79.33
        2. group Id
          BG001
          spread
          22.763
          value
          73.22
        3. group Id
          BG002
          spread
          17.457
          value
          79.90
        4. group Id
          BG003
          spread
          10.358
          value
          57.07
        5. group Id
          BG004
          spread
          18.770
          value
          77.70
        6. group Id
          BG005
          spread
          19.076
          value
          73.87
      denoms
      1. counts
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          100
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    population Description
    Number analyzed is the number of participants with data available for weight at the Baseline.
    title
    Weight
    unit Of Measure
    kg
  8. classes
    1. 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
          12
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          15
        title
        Tobacco
      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
          6
        5. group Id
          BG004
          value
          15
        6. group Id
          BG005
          value
          21
        title
        Cigarette
      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
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        title
        Cigar
      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
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        title
        Pipe
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          20
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          38
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Data for substance use was collected only for sqEC and sqNSCLC cohorts. Number analyzed is the number of participants with data available for substance use at Baseline.
    title
    Substance Use
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          65
        title
        Never Smoked
      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
          3
        5. group Id
          BG004
          value
          7
        6. group Id
          BG005
          value
          10
        title
        Current Smoker
      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
          16
        5. group Id
          BG004
          value
          10
        6. group Id
          BG005
          value
          26
        title
        Former Smoker
      denoms
      1. counts
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          15
        3. group Id
          BG002
          value
          35
        4. group Id
          BG003
          value
          21
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          101
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Smoking Classification
    unit Of Measure
    Participants
population Description
Safety Analysis Set included all participants who received any amount of study drug.

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Preserved source evidence · Not medical advice