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NCT01675765 · BASELINE

Baseline characteristics

Safety and Efficacy of Listeria in Combination With Chemotherapy as Front-line Treatment for Malignant Pleural Mesothelioma · Source last updated 2020-09-30

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
      38
    2. group Id
      BG001
      value
      22
    3. group Id
      BG002
      value
      60
    units
    Participants
groups
  1. description
    Weeks 1 and 3: CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: CRS-207 Maintenance Vaccinations: CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy plus chemotherapy: live attenuated double deleted Lm
    id
    BG000
    title
    Immunotherapy Plus Chemotherapy
  2. description
    Weeks 1 and 3: cyclophosphamide (200 mg/m\^2), CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: cyclophosphamide one day before CRS-207 Maintenance Vaccinations: cyclophosphamide one day before CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy with cyclophosphamide plus chemotherapy: live attenuated double deleted Lm
    id
    BG001
    title
    Immunotherapy With Cyclophosphamide Plus Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          15
      title
      <65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          45
      title
      >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          9
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          51
        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
          0
        3. group Id
          BG002
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          59
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          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
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          58
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          spread
          16.203
          value
          81.63
        2. group Id
          BG001
          spread
          12.340
          value
          73.83
        3. group Id
          BG002
          spread
          15.271
          value
          78.77
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.295
          value
          174.51
        2. group Id
          BG001
          spread
          7.102
          value
          168.41
        3. group Id
          BG002
          spread
          8.359
          value
          172.28
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    cm
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.3292
          value
          26.702
        2. group Id
          BG001
          spread
          4.4584
          value
          26.076
        3. group Id
          BG002
          spread
          4.3498
          value
          26.473
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Mass Index
    unit Of Measure
    kg/m^2
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.2230
          value
          1.982
        2. group Id
          BG001
          spread
          0.1756
          value
          1.852
        3. group Id
          BG002
          spread
          0.2148
          value
          1.935
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Surface Area
    unit Of Measure
    m^2
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      38
    2. group Id
      BG001
      value
      22
    3. group Id
      BG002
      value
      60
    units
    Participants
groups
  1. description
    Weeks 1 and 3: CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: CRS-207 Maintenance Vaccinations: CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy plus chemotherapy: live attenuated double deleted Lm
    id
    BG000
    title
    Immunotherapy Plus Chemotherapy
  2. description
    Weeks 1 and 3: cyclophosphamide (200 mg/m\^2), CRS-207 (1 × 10\^9 CFU) Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m\^2) and cisplatin (75 mg/m\^2) Weeks 23 and 26: cyclophosphamide one day before CRS-207 Maintenance Vaccinations: cyclophosphamide one day before CRS-207 every 8 weeks (starting at Week 34) until disease progression Immunotherapy with cyclophosphamide plus chemotherapy: live attenuated double deleted Lm
    id
    BG001
    title
    Immunotherapy With Cyclophosphamide Plus Chemotherapy
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          15
      title
      <65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          29
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          45
      title
      >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Customized
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          9
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          34
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          51
        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
          0
        3. group Id
          BG002
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          59
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          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
          2
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          36
        2. group Id
          BG001
          value
          22
        3. group Id
          BG002
          value
          58
        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
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        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
          spread
          16.203
          value
          81.63
        2. group Id
          BG001
          spread
          12.340
          value
          73.83
        3. group Id
          BG002
          spread
          15.271
          value
          78.77
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Weight
    unit Of Measure
    kg
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          8.295
          value
          174.51
        2. group Id
          BG001
          spread
          7.102
          value
          168.41
        3. group Id
          BG002
          spread
          8.359
          value
          172.28
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Height
    unit Of Measure
    cm
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.3292
          value
          26.702
        2. group Id
          BG001
          spread
          4.4584
          value
          26.076
        3. group Id
          BG002
          spread
          4.3498
          value
          26.473
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Mass Index
    unit Of Measure
    kg/m^2
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0.2230
          value
          1.982
        2. group Id
          BG001
          spread
          0.1756
          value
          1.852
        3. group Id
          BG002
          spread
          0.2148
          value
          1.935
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Body Surface Area
    unit Of Measure
    m^2

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Preserved source evidence · Not medical advice