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NCT03735121 · BASELINE

Baseline characteristics

A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer · Source last updated 2025-12-05

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
      13
    2. group Id
      BG001
      value
      15
    3. group Id
      BG002
      value
      39
    4. group Id
      BG003
      value
      124
    5. group Id
      BG004
      value
      247
    6. group Id
      BG005
      value
      438
    units
    Participants
groups
  1. description
    Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection on Cycle 1 Day 1 (1 cycle=21 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
    id
    BG000
    title
    Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg
  2. description
    Participants received atezolizumab, 1200 mg, co-mixed with rHuPH20, as SC injection, Q2W, on Day 1 of the first 3 cycles (Cycle 1-3=14 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
    id
    BG001
    title
    Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg
  3. description
    Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection, Q3W, on Day 1 of first 3 cycles, followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 for subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
    id
    BG002
    title
    Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg
  4. description
    Participants received atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.
    id
    BG003
    title
    Part 2: Atezolizumab IV 1200 mg
  5. description
    Participants received atezolizumab, 1875 mg, co-formulated with rHuPH20, as SC injection, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.
    id
    BG004
    title
    Part 2: Atezolizumab SC 1875 mg
  6. description
    Total of all reporting groups
    id
    BG005
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          58
        5. group Id
          BG004
          value
          137
        6. group Id
          BG005
          value
          229
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          66
        5. group Id
          BG004
          value
          110
        6. group Id
          BG005
          value
          209
        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
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          42
        5. group Id
          BG004
          value
          72
        6. group Id
          BG005
          value
          140
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          82
        5. group Id
          BG004
          value
          175
        6. group Id
          BG005
          value
          298
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          15
        6. group Id
          BG005
          value
          24
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          33
        5. group Id
          BG004
          value
          47
        6. group Id
          BG005
          value
          85
        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
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          3
        title
        Native Hawaiian or Other Pacific Islander
      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
          2
        6. group Id
          BG005
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          36
        4. group Id
          BG003
          value
          74
        5. group Id
          BG004
          value
          174
        6. group Id
          BG005
          value
          303
        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
          5
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          11
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          9
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          36
        5. group Id
          BG004
          value
          61
        6. group Id
          BG005
          value
          115
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          88
        5. group Id
          BG004
          value
          185
        6. group Id
          BG005
          value
          314
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          8
        title
        Not Stated
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Part 1: Intent-to-treat (ITT) population included all enrolled participants. Part 2: Full analysis set (FAS) included all participants who were randomized with participants grouped per their assigned treatment. HCPs who administered the study treatment to participants were not enrolled in the study. To evaluate the HCPs' reported experience with administration of atezolizumab SC \& IV, the HCPs were asked to complete 2 questionnaires. No baseline data were collected for the HCPs in this study.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      13
    2. group Id
      BG001
      value
      15
    3. group Id
      BG002
      value
      39
    4. group Id
      BG003
      value
      124
    5. group Id
      BG004
      value
      247
    6. group Id
      BG005
      value
      438
    units
    Participants
groups
  1. description
    Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection on Cycle 1 Day 1 (1 cycle=21 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
    id
    BG000
    title
    Part 1 Cohort 1: Atezolizumab SC Co-mix 1800 mg
  2. description
    Participants received atezolizumab, 1200 mg, co-mixed with rHuPH20, as SC injection, Q2W, on Day 1 of the first 3 cycles (Cycle 1-3=14 days), followed by atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
    id
    BG001
    title
    Part 1 Cohort 2: Atezolizumab SC Co-mix 1200 mg
  3. description
    Participants received atezolizumab, 1800 mg, co-mixed with rHuPH20, as SC injection, Q3W, on Day 1 of first 3 cycles, followed by atezolizumab, 1200 mg, as an IV infusion, Q3W on Day 1 for subsequent cycles (1 cycle=21 days) until PD, loss of clinical benefit, unacceptable toxicity, or withdrawal of consent.
    id
    BG002
    title
    Part 1 Cohort 3: Atezolizumab SC Co-mix 1800 mg
  4. description
    Participants received atezolizumab, 1200 mg, as an IV infusion, Q3W, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.
    id
    BG003
    title
    Part 2: Atezolizumab IV 1200 mg
  5. description
    Participants received atezolizumab, 1875 mg, co-formulated with rHuPH20, as SC injection, on Day 1 of each cycle (1 cycle=21 days) until PD, loss of clinical benefit, or unacceptable toxicity.
    id
    BG004
    title
    Part 2: Atezolizumab SC 1875 mg
  6. description
    Total of all reporting groups
    id
    BG005
    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
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          58
        5. group Id
          BG004
          value
          137
        6. group Id
          BG005
          value
          229
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          66
        5. group Id
          BG004
          value
          110
        6. group Id
          BG005
          value
          209
        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
          value
          8
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          42
        5. group Id
          BG004
          value
          72
        6. group Id
          BG005
          value
          140
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          27
        4. group Id
          BG003
          value
          82
        5. group Id
          BG004
          value
          175
        6. group Id
          BG005
          value
          298
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          9
        5. group Id
          BG004
          value
          15
        6. group Id
          BG005
          value
          24
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          33
        5. group Id
          BG004
          value
          47
        6. group Id
          BG005
          value
          85
        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
          2
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          3
        title
        Native Hawaiian or Other Pacific Islander
      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
          2
        6. group Id
          BG005
          value
          3
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          36
        4. group Id
          BG003
          value
          74
        5. group Id
          BG004
          value
          174
        6. group Id
          BG005
          value
          303
        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
          5
        5. group Id
          BG004
          value
          6
        6. group Id
          BG005
          value
          11
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          2
        6. group Id
          BG005
          value
          9
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          12
        4. group Id
          BG003
          value
          36
        5. group Id
          BG004
          value
          61
        6. group Id
          BG005
          value
          115
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          25
        4. group Id
          BG003
          value
          88
        5. group Id
          BG004
          value
          185
        6. group Id
          BG005
          value
          314
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          8
        title
        Not Stated
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          1
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Part 1: Intent-to-treat (ITT) population included all enrolled participants. Part 2: Full analysis set (FAS) included all participants who were randomized with participants grouped per their assigned treatment. HCPs who administered the study treatment to participants were not enrolled in the study. To evaluate the HCPs' reported experience with administration of atezolizumab SC \& IV, the HCPs were asked to complete 2 questionnaires. No baseline data were collected for the HCPs in this study.

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