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NCT02784171 · BASELINE

Baseline characteristics

Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma · Source last updated 2024-12-10

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
      21
    2. group Id
      BG001
      value
      19
    3. group Id
      BG002
      value
      40
    4. group Id
      BG003
      value
      218
    5. group Id
      BG004
      value
      222
    6. group Id
      BG005
      value
      520
    units
    Participants
groups
  1. description
    Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin Pemetrexed
    id
    BG000
    title
    Arm A - Cisplatin/Pemetrexed (Phase II)
  2. description
    Pembrolizumab 200 mg\* IV Day 1 over 30 min every 21 days for a total of 2 years Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin Pemetrexed Pembrolizumab
    id
    BG001
    title
    Arm B - Cisplatin/Pemetrexed/Pembrolizumab (Phase II)
  3. description
    Pembrolizumab 200 mg\* IV 30 min Day 1 every 21 days for a total of 2 years Pembrolizumab
    id
    BG002
    title
    Arm C - Pembrolizumab (Phase II Only)
  4. description
    Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin Pemetrexed
    id
    BG003
    title
    Arm A - Cisplatin/Pemetrexed (Phase III)
  5. description
    Pembrolizumab 200 mg\* IV Day 1 over 30 min every 21 days for a total of 2 years Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles
    id
    BG004
    title
    Arm B - Cisplatin/Pemetrexed/Pembrolizumab (Phase III)
  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
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          61
        5. group Id
          BG004
          value
          42
        6. group Id
          BG005
          value
          129
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          157
        5. group Id
          BG004
          value
          180
        6. group Id
          BG005
          value
          391
        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
          lower Limit
          65.4
          upper Limit
          74.2
          value
          68.5
        2. group Id
          BG001
          lower Limit
          63.6
          upper Limit
          73
          value
          69
        3. group Id
          BG002
          lower Limit
          62
          upper Limit
          73.8
          value
          69.1
        4. group Id
          BG003
          lower Limit
          63.5
          upper Limit
          75.7
          value
          70.8
        5. group Id
          BG004
          lower Limit
          66.4
          upper Limit
          75.3
          value
          70.8
        6. group Id
          BG005
          lower Limit
          65.1
          upper Limit
          75.1
          value
          70.5
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          57
        6. group Id
          BG005
          value
          116
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          36
        4. group Id
          BG003
          value
          168
        5. group Id
          BG004
          value
          165
        6. group Id
          BG005
          value
          404
        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
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        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
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          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
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          172
        5. group Id
          BG004
          value
          175
        6. group Id
          BG005
          value
          423
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          45
        5. group Id
          BG004
          value
          46
        6. group Id
          BG005
          value
          93
        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
          15
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          67
        5. group Id
          BG004
          value
          70
        6. group Id
          BG005
          value
          185
      title
      Canada
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          106
        5. group Id
          BG004
          value
          106
        6. group Id
          BG005
          value
          244
      title
      Italy
    3. 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
          45
        5. group Id
          BG004
          value
          46
        6. group Id
          BG005
          value
          91
      title
      France
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      21
    2. group Id
      BG001
      value
      19
    3. group Id
      BG002
      value
      40
    4. group Id
      BG003
      value
      218
    5. group Id
      BG004
      value
      222
    6. group Id
      BG005
      value
      520
    units
    Participants
groups
  1. description
    Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin Pemetrexed
    id
    BG000
    title
    Arm A - Cisplatin/Pemetrexed (Phase II)
  2. description
    Pembrolizumab 200 mg\* IV Day 1 over 30 min every 21 days for a total of 2 years Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin Pemetrexed Pembrolizumab
    id
    BG001
    title
    Arm B - Cisplatin/Pemetrexed/Pembrolizumab (Phase II)
  3. description
    Pembrolizumab 200 mg\* IV 30 min Day 1 every 21 days for a total of 2 years Pembrolizumab
    id
    BG002
    title
    Arm C - Pembrolizumab (Phase II Only)
  4. description
    Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin Pemetrexed
    id
    BG003
    title
    Arm A - Cisplatin/Pemetrexed (Phase III)
  5. description
    Pembrolizumab 200 mg\* IV Day 1 over 30 min every 21 days for a total of 2 years Pemetrexed 500 mg/m2 IV Day 1 every 21 days for 6 cycles Cisplatin 75 mg/m2 IV Day 1 every 21 days for 6 cycles
    id
    BG004
    title
    Arm B - Cisplatin/Pemetrexed/Pembrolizumab (Phase III)
  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
          5
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          14
        4. group Id
          BG003
          value
          61
        5. group Id
          BG004
          value
          42
        6. group Id
          BG005
          value
          129
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          16
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          26
        4. group Id
          BG003
          value
          157
        5. group Id
          BG004
          value
          180
        6. group Id
          BG005
          value
          391
        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
          lower Limit
          65.4
          upper Limit
          74.2
          value
          68.5
        2. group Id
          BG001
          lower Limit
          63.6
          upper Limit
          73
          value
          69
        3. group Id
          BG002
          lower Limit
          62
          upper Limit
          73.8
          value
          69.1
        4. group Id
          BG003
          lower Limit
          63.5
          upper Limit
          75.7
          value
          70.8
        5. group Id
          BG004
          lower Limit
          66.4
          upper Limit
          75.3
          value
          70.8
        6. group Id
          BG005
          lower Limit
          65.1
          upper Limit
          75.1
          value
          70.5
    dispersion Type
    INTER_QUARTILE_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          50
        5. group Id
          BG004
          value
          57
        6. group Id
          BG005
          value
          116
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          19
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          36
        4. group Id
          BG003
          value
          168
        5. group Id
          BG004
          value
          165
        6. group Id
          BG005
          value
          404
        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
          1
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          1
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        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
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          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
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          20
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          38
        4. group Id
          BG003
          value
          172
        5. group Id
          BG004
          value
          175
        6. group Id
          BG005
          value
          423
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        6. group Id
          BG005
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          45
        5. group Id
          BG004
          value
          46
        6. group Id
          BG005
          value
          93
        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
          15
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          22
        4. group Id
          BG003
          value
          67
        5. group Id
          BG004
          value
          70
        6. group Id
          BG005
          value
          185
      title
      Canada
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          18
        4. group Id
          BG003
          value
          106
        5. group Id
          BG004
          value
          106
        6. group Id
          BG005
          value
          244
      title
      Italy
    3. 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
          45
        5. group Id
          BG004
          value
          46
        6. group Id
          BG005
          value
          91
      title
      France
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

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Preserved source evidence · Not medical advice