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NCT02357147 · BASELINE

Baseline characteristics

Study of the Safety and Efficacy of Amatuximab in Combination With Pemetrexed and Cisplatin in Subjects With Unresectable Malignant Pleural Mesothelioma (MPM) · Source last updated 2020-03-17

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
      52
    2. group Id
      BG001
      value
      54
    3. group Id
      BG002
      value
      106
    units
    Participants
groups
  1. description
    During Combination Treatment Phase, participants received amatuximab 5 mg/kg, infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.
    id
    BG000
    title
    Amatuximab + Pemetrexed + Cisplatin
  2. description
    During Combination Treatment Phase, participants received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.
    id
    BG001
    title
    Placebo + Pemetrexed + Cisplatin
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.08
          value
          67.9
        2. group Id
          BG001
          spread
          7.96
          value
          66.9
        3. group Id
          BG002
          spread
          7.08
          value
          67.4
    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
          15
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          29
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          77
        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
          7
        3. group Id
          BG002
          value
          8
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          79
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          19
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          91
        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
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          13
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
The safety analysis set was defined as all randomized participants who received at least 1 dose of study drug.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      52
    2. group Id
      BG001
      value
      54
    3. group Id
      BG002
      value
      106
    units
    Participants
groups
  1. description
    During Combination Treatment Phase, participants received amatuximab 5 mg/kg, infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and continued to receive amatuximab 5 mg/kg, infusion, intravenously, once weekly until disease progression.
    id
    BG000
    title
    Amatuximab + Pemetrexed + Cisplatin
  2. description
    During Combination Treatment Phase, participants received placebo matched to amatuximab infusion, intravenously, once weekly in 21-day cycles and pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2, infusion, intravenously, on Day 1 of each 21-day cycle for 6 cycles. Following completion of the Combination Treatment Phase, participants who had not progressed entered the Maintenance Phase and received placebo matched to amatuximab infusion, intravenously, once weekly until disease progression.
    id
    BG001
    title
    Placebo + Pemetrexed + Cisplatin
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          6.08
          value
          67.9
        2. group Id
          BG001
          spread
          7.96
          value
          66.9
        3. group Id
          BG002
          spread
          7.08
          value
          67.4
    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
          15
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          29
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          37
        2. group Id
          BG001
          value
          40
        3. group Id
          BG002
          value
          77
        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
          7
        3. group Id
          BG002
          value
          8
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          42
        2. group Id
          BG001
          value
          37
        3. group Id
          BG002
          value
          79
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          19
        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
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          45
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          91
        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
          6
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          13
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
population Description
The safety analysis set was defined as all randomized participants who received at least 1 dose of study drug.

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Preserved source evidence · Not medical advice