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NCT02142738 · BASELINE

Baseline characteristics

Study of Pembrolizumab (MK-3475) Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (MK-3475-024/KEYNOTE-024) · Source last updated 2022-06-13

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
      154
    2. group Id
      BG001
      value
      151
    3. group Id
      BG002
      value
      305
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.
    id
    BG000
    title
    Pembrolizumab
  2. description
    Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m\^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m\^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m\^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).
    id
    BG001
    title
    SOC Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.1
          value
          63.9
        2. group Id
          BG001
          spread
          9.5
          value
          64.6
        3. group Id
          BG002
          spread
          9.8
          value
          64.2
    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
          62
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          118
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          187
        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
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          148
        2. group Id
          BG001
          value
          135
        3. group Id
          BG002
          value
          283
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          16
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          46
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          125
        2. group Id
          BG001
          value
          126
        3. group Id
          BG002
          value
          251
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          107
      title
      ECOG = 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          98
        3. group Id
          BG002
          value
          197
      title
      ECOG = 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      ECOG = 2
    description
    Eastern Cooperative Oncology Group (ECOG) Performance. ECOG is presented where 0 = Fully active, no performance restrictions; 1 = Strenuous physical activity restricted, fully ambulatory \& able to carry out light work; and 2 = In bed \<50% of the time, ambulatory and capable of all self-care, but unable to carry out any work activities.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Status (0, 1 or 2)
    unit Of Measure
    Rating
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          108
        3. group Id
          BG002
          value
          212
      title
      ADENOCARCINOMA
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      ADENOSQUAMOUS
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      LARGE CELL CARCINOMA
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          12
      title
      NON-SQUAMOUS CELL CARCINOMA
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          12
      title
      POORLY DIFFERENTIATED
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      SARCOMATOID
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          55
      title
      SQUAMOUS CELL CARCINOMA
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      POORLY DIFFERENTIATED SQUAMOUS CELL CARCINOMA
    description
    Participants were categorized according to the histology of their carcinoma
    param Type
    NUMBER
    title
    Histology
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          133
        2. group Id
          BG001
          value
          132
        3. group Id
          BG002
          value
          265
      title
      Non-East Asia
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          40
      title
      East Asia
    description
    Count of Participants enrolled in sites in Non-East Asia and East Asia
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region of Enrolling Site
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      154
    2. group Id
      BG001
      value
      151
    3. group Id
      BG002
      value
      305
    units
    Participants
groups
  1. description
    Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.
    id
    BG000
    title
    Pembrolizumab
  2. description
    Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m\^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m\^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m\^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m\^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).
    id
    BG001
    title
    SOC Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.1
          value
          63.9
        2. group Id
          BG001
          spread
          9.5
          value
          64.6
        3. group Id
          BG002
          spread
          9.8
          value
          64.2
    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
          62
        2. group Id
          BG001
          value
          56
        3. group Id
          BG002
          value
          118
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          187
        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
          1
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          6
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          148
        2. group Id
          BG001
          value
          135
        3. group Id
          BG002
          value
          283
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          16
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          21
        3. group Id
          BG002
          value
          46
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          125
        2. group Id
          BG001
          value
          126
        3. group Id
          BG002
          value
          251
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          54
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          107
      title
      ECOG = 0
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          99
        2. group Id
          BG001
          value
          98
        3. group Id
          BG002
          value
          197
      title
      ECOG = 1
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
      title
      ECOG = 2
    description
    Eastern Cooperative Oncology Group (ECOG) Performance. ECOG is presented where 0 = Fully active, no performance restrictions; 1 = Strenuous physical activity restricted, fully ambulatory \& able to carry out light work; and 2 = In bed \<50% of the time, ambulatory and capable of all self-care, but unable to carry out any work activities.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Status (0, 1 or 2)
    unit Of Measure
    Rating
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          108
        3. group Id
          BG002
          value
          212
      title
      ADENOCARCINOMA
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      ADENOSQUAMOUS
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          4
      title
      LARGE CELL CARCINOMA
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          12
      title
      NON-SQUAMOUS CELL CARCINOMA
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          12
      title
      POORLY DIFFERENTIATED
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
      title
      SARCOMATOID
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          26
        3. group Id
          BG002
          value
          55
      title
      SQUAMOUS CELL CARCINOMA
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      POORLY DIFFERENTIATED SQUAMOUS CELL CARCINOMA
    description
    Participants were categorized according to the histology of their carcinoma
    param Type
    NUMBER
    title
    Histology
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          133
        2. group Id
          BG001
          value
          132
        3. group Id
          BG002
          value
          265
      title
      Non-East Asia
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          40
      title
      East Asia
    description
    Count of Participants enrolled in sites in Non-East Asia and East Asia
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Geographic Region of Enrolling Site
    unit Of Measure
    Participants

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