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NCT02514447 · BASELINE

Baseline characteristics

Trilaciclib (G1T28) in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy · Source last updated 2025-09-25

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
      29
    2. group Id
      BG001
      value
      30
    3. group Id
      BG002
      value
      32
    4. group Id
      BG003
      value
      2
    5. group Id
      BG004
      value
      3
    6. group Id
      BG005
      value
      4
    7. group Id
      BG006
      value
      8
    8. group Id
      BG007
      value
      7
    9. group Id
      BG008
      value
      8
    10. group Id
      BG009
      value
      123
    units
    Participants
groups
  1. description
    Patients in Parts 2a and 2b were randomized 1:2 to placebo. Patients received placebo administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of placebo on Days 1 to 5, patients received IV topotecan (1.5 mg/m²). Placebos Topotecan
    id
    BG000
    title
    Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b
  2. description
    Patients in Part 2a were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²). Trilaciclib Topotecan
    id
    BG001
    title
    Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a
  3. description
    Patients in Part 2b were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.5 mg/m²). Trilaciclib Topotecan
    id
    BG002
    title
    Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b
  4. description
    Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.50 mg/m²).
    id
    BG003
    title
    Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1
  5. description
    Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.25 mg/m²).
    id
    BG004
    title
    Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1
  6. description
    Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
    id
    BG005
    title
    Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1
  7. description
    Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
    id
    BG006
    title
    Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1
  8. description
    Patients received trilaciclib (280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
    id
    BG007
    title
    Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1
  9. description
    Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.0 mg/m²).
    id
    BG008
    title
    Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. 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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          71
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          52
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.1
          value
          64
        2. group Id
          BG001
          spread
          8.2
          value
          63
        3. group Id
          BG002
          spread
          7.3
          value
          62
        4. group Id
          BG003
          spread
          9.2
          value
          66
        5. group Id
          BG004
          spread
          9.1
          value
          69
        6. group Id
          BG005
          spread
          6.1
          value
          71
        7. group Id
          BG006
          spread
          8.4
          value
          62
        8. group Id
          BG007
          spread
          8.9
          value
          63
        9. group Id
          BG008
          spread
          10.4
          value
          69
        10. group Id
          BG009
          spread
          8.2
          value
          64
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          52
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          71
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          31
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          8
        10. group Id
          BG009
          value
          121
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. 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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          7
        10. group Id
          BG009
          value
          114
        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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          8
        10. group Id
          BG009
          value
          91
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          26
      title
      Serbia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
      title
      Belgium
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
      title
      North Macedonia
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          3
      title
      Croatia
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          29
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          7
        10. group Id
          BG009
          value
          112
        title
        Grade 0-1
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          11
        title
        Grade 2
    description
    The ECOG Performance Status Scale describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Grade 0= Fully active, able to carry on all pre-disease performance without restriction. Grade 1= Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2= Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          16.37
          value
          72.7
        2. group Id
          BG001
          spread
          17.08
          value
          71.9
        3. group Id
          BG002
          spread
          17.28
          value
          75.7
        4. group Id
          BG003
          spread
          22.20
          value
          95.2
        5. group Id
          BG004
          spread
          23.59
          value
          72.6
        6. group Id
          BG005
          spread
          23.05
          value
          90.1
        7. group Id
          BG006
          spread
          29.88
          value
          73.5
        8. group Id
          BG007
          spread
          19.25
          value
          86.3
        9. group Id
          BG008
          spread
          15.00
          value
          67.8
        10. group Id
          BG009
          spread
          18.55
          value
          74.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Weight at Screening
    unit Of Measure
    kg
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.85
          value
          166.2
        2. group Id
          BG001
          spread
          9.49
          value
          169.0
        3. group Id
          BG002
          spread
          10.01
          value
          172.2
        4. group Id
          BG003
          spread
          1.27
          value
          176.2
        5. group Id
          BG004
          spread
          18.53
          value
          169.7
        6. group Id
          BG005
          spread
          5.42
          value
          175.3
        7. group Id
          BG006
          spread
          12.93
          value
          165.2
        8. group Id
          BG007
          spread
          3.49
          value
          175.3
        9. group Id
          BG008
          spread
          16.74
          value
          167.4
        10. group Id
          BG009
          spread
          10.56
          value
          169.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height at Screening
    unit Of Measure
    cm
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.239
          value
          26.13
        2. group Id
          BG001
          spread
          4.820
          value
          25.04
        3. group Id
          BG002
          spread
          5.113
          value
          25.43
        4. group Id
          BG003
          spread
          7.595
          value
          30.72
        5. group Id
          BG004
          spread
          2.430
          value
          24.63
        6. group Id
          BG005
          spread
          6.218
          value
          29.05
        7. group Id
          BG006
          spread
          7.164
          value
          26.06
        8. group Id
          BG007
          spread
          6.232
          value
          28.11
        9. group Id
          BG008
          spread
          3.502
          value
          24.15
        10. group Id
          BG009
          spread
          4.984
          value
          25.79
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    BMI at Screening
    unit Of Measure
    kg/m^2
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.234
          value
          1.80
        2. group Id
          BG001
          spread
          0.234
          value
          1.81
        3. group Id
          BG002
          spread
          0.234
          value
          1.88
        4. group Id
          BG003
          spread
          0.200
          value
          2.11
        5. group Id
          BG004
          spread
          0.398
          value
          1.83
        6. group Id
          BG005
          spread
          0.282
          value
          2.05
        7. group Id
          BG006
          spread
          0.398
          value
          1.79
        8. group Id
          BG007
          spread
          0.185
          value
          2.01
        9. group Id
          BG008
          spread
          0.274
          value
          1.76
        10. group Id
          BG009
          spread
          0.255
          value
          1.85
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Surface Area at Screening
    unit Of Measure
    m^2
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      29
    2. group Id
      BG001
      value
      30
    3. group Id
      BG002
      value
      32
    4. group Id
      BG003
      value
      2
    5. group Id
      BG004
      value
      3
    6. group Id
      BG005
      value
      4
    7. group Id
      BG006
      value
      8
    8. group Id
      BG007
      value
      7
    9. group Id
      BG008
      value
      8
    10. group Id
      BG009
      value
      123
    units
    Participants
groups
  1. description
    Patients in Parts 2a and 2b were randomized 1:2 to placebo. Patients received placebo administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of placebo on Days 1 to 5, patients received IV topotecan (1.5 mg/m²). Placebos Topotecan
    id
    BG000
    title
    Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b
  2. description
    Patients in Part 2a were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²). Trilaciclib Topotecan
    id
    BG001
    title
    Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a
  3. description
    Patients in Part 2b were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.5 mg/m²). Trilaciclib Topotecan
    id
    BG002
    title
    Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b
  4. description
    Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.50 mg/m²).
    id
    BG003
    title
    Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1
  5. description
    Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.25 mg/m²).
    id
    BG004
    title
    Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1
  6. description
    Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
    id
    BG005
    title
    Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1
  7. description
    Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
    id
    BG006
    title
    Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1
  8. description
    Patients received trilaciclib (280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
    id
    BG007
    title
    Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1
  9. description
    Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.0 mg/m²).
    id
    BG008
    title
    Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1
  10. description
    Total of all reporting groups
    id
    BG009
    title
    Total
measures
  1. 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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          4
        9. group Id
          BG008
          value
          2
        10. group Id
          BG009
          value
          71
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          1
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          3
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          3
        9. group Id
          BG008
          value
          6
        10. group Id
          BG009
          value
          52
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.1
          value
          64
        2. group Id
          BG001
          spread
          8.2
          value
          63
        3. group Id
          BG002
          spread
          7.3
          value
          62
        4. group Id
          BG003
          spread
          9.2
          value
          66
        5. group Id
          BG004
          spread
          9.1
          value
          69
        6. group Id
          BG005
          spread
          6.1
          value
          71
        7. group Id
          BG006
          spread
          8.4
          value
          62
        8. group Id
          BG007
          spread
          8.9
          value
          63
        9. group Id
          BG008
          spread
          10.4
          value
          69
        10. group Id
          BG009
          spread
          8.2
          value
          64
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    Years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          10
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          5
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          52
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          3
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          4
        10. group Id
          BG009
          value
          71
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          30
        3. group Id
          BG002
          value
          31
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          8
        10. group Id
          BG009
          value
          121
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. 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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
        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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          1
        8. group Id
          BG007
          value
          1
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          6
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          29
        3. group Id
          BG002
          value
          30
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          7
        8. group Id
          BG007
          value
          6
        9. group Id
          BG008
          value
          7
        10. group Id
          BG009
          value
          114
        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
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          8
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          8
        10. group Id
          BG009
          value
          91
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          26
      title
      Serbia
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          1
      title
      Belgium
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          2
      title
      North Macedonia
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          0
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          0
        10. group Id
          BG009
          value
          3
      title
      Croatia
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          29
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          3
        6. group Id
          BG005
          value
          4
        7. group Id
          BG006
          value
          6
        8. group Id
          BG007
          value
          7
        9. group Id
          BG008
          value
          7
        10. group Id
          BG009
          value
          112
        title
        Grade 0-1
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        7. group Id
          BG006
          value
          2
        8. group Id
          BG007
          value
          0
        9. group Id
          BG008
          value
          1
        10. group Id
          BG009
          value
          11
        title
        Grade 2
    description
    The ECOG Performance Status Scale describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). Grade 0= Fully active, able to carry on all pre-disease performance without restriction. Grade 1= Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2= Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          16.37
          value
          72.7
        2. group Id
          BG001
          spread
          17.08
          value
          71.9
        3. group Id
          BG002
          spread
          17.28
          value
          75.7
        4. group Id
          BG003
          spread
          22.20
          value
          95.2
        5. group Id
          BG004
          spread
          23.59
          value
          72.6
        6. group Id
          BG005
          spread
          23.05
          value
          90.1
        7. group Id
          BG006
          spread
          29.88
          value
          73.5
        8. group Id
          BG007
          spread
          19.25
          value
          86.3
        9. group Id
          BG008
          spread
          15.00
          value
          67.8
        10. group Id
          BG009
          spread
          18.55
          value
          74.7
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Weight at Screening
    unit Of Measure
    kg
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.85
          value
          166.2
        2. group Id
          BG001
          spread
          9.49
          value
          169.0
        3. group Id
          BG002
          spread
          10.01
          value
          172.2
        4. group Id
          BG003
          spread
          1.27
          value
          176.2
        5. group Id
          BG004
          spread
          18.53
          value
          169.7
        6. group Id
          BG005
          spread
          5.42
          value
          175.3
        7. group Id
          BG006
          spread
          12.93
          value
          165.2
        8. group Id
          BG007
          spread
          3.49
          value
          175.3
        9. group Id
          BG008
          spread
          16.74
          value
          167.4
        10. group Id
          BG009
          spread
          10.56
          value
          169.5
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height at Screening
    unit Of Measure
    cm
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.239
          value
          26.13
        2. group Id
          BG001
          spread
          4.820
          value
          25.04
        3. group Id
          BG002
          spread
          5.113
          value
          25.43
        4. group Id
          BG003
          spread
          7.595
          value
          30.72
        5. group Id
          BG004
          spread
          2.430
          value
          24.63
        6. group Id
          BG005
          spread
          6.218
          value
          29.05
        7. group Id
          BG006
          spread
          7.164
          value
          26.06
        8. group Id
          BG007
          spread
          6.232
          value
          28.11
        9. group Id
          BG008
          spread
          3.502
          value
          24.15
        10. group Id
          BG009
          spread
          4.984
          value
          25.79
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    BMI at Screening
    unit Of Measure
    kg/m^2
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.234
          value
          1.80
        2. group Id
          BG001
          spread
          0.234
          value
          1.81
        3. group Id
          BG002
          spread
          0.234
          value
          1.88
        4. group Id
          BG003
          spread
          0.200
          value
          2.11
        5. group Id
          BG004
          spread
          0.398
          value
          1.83
        6. group Id
          BG005
          spread
          0.282
          value
          2.05
        7. group Id
          BG006
          spread
          0.398
          value
          1.79
        8. group Id
          BG007
          spread
          0.185
          value
          2.01
        9. group Id
          BG008
          spread
          0.274
          value
          1.76
        10. group Id
          BG009
          spread
          0.255
          value
          1.85
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Surface Area at Screening
    unit Of Measure
    m^2

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