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NCT02576977 · BASELINE

Baseline characteristics

Study of Pomalidomide and Low Dose Dexamethasone With or Without Pembrolizumab (MK-3475) in Refractory or Relapsed and Refractory Multiple Myeloma (rrMM) (MK-3475-183/KEYNOTE-183) · Source last updated 2021-10-08

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
      126
    2. group Id
      BG001
      value
      125
    3. group Id
      BG002
      value
      251
    units
    Participants
groups
  1. description
    Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
    id
    BG000
    title
    Pembrolizumab+Pomalidomide+Dexamethasone
  2. description
    Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
    id
    BG001
    title
    Standard of Care (SOC) Pomalidomide+Dexamethasone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.3
          value
          65.5
        2. group Id
          BG001
          spread
          10.0
          value
          66.4
        3. group Id
          BG002
          spread
          9.6
          value
          65.9
    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
          48
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          94
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          78
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          157
        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
          8
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          13
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          110
        2. group Id
          BG001
          value
          117
        3. group Id
          BG002
          value
          227
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          11
        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
          17
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          29
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          24
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          187
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        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
          108
        2. group Id
          BG001
          value
          108
        3. group Id
          BG002
          value
          216
        title
        Refractory to Lenalidomide
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          35
        title
        Sensitive to Lenalidomide
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Status (Refractory vs. Sensitive to Lenalidomide)
    unit Of Measure
    Participants
population Description
The analysis population included all randomized participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      126
    2. group Id
      BG001
      value
      125
    3. group Id
      BG002
      value
      251
    units
    Participants
groups
  1. description
    Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 every 3 weeks (Q3W) PLUS pomalidomide 4 mg orally (PO) on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
    id
    BG000
    title
    Pembrolizumab+Pomalidomide+Dexamethasone
  2. description
    Participants receive pomalidomide 4 mg PO on Days 1 to 21 of each 28-day cycle PLUS dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle.
    id
    BG001
    title
    Standard of Care (SOC) Pomalidomide+Dexamethasone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.3
          value
          65.5
        2. group Id
          BG001
          spread
          10.0
          value
          66.4
        3. group Id
          BG002
          spread
          9.6
          value
          65.9
    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
          48
        2. group Id
          BG001
          value
          46
        3. group Id
          BG002
          value
          94
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          78
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          157
        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
          8
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          13
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          110
        2. group Id
          BG001
          value
          117
        3. group Id
          BG002
          value
          227
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          11
        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
          17
        2. group Id
          BG001
          value
          12
        3. group Id
          BG002
          value
          29
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          3
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          24
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          92
        2. group Id
          BG001
          value
          95
        3. group Id
          BG002
          value
          187
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          5
        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
          108
        2. group Id
          BG001
          value
          108
        3. group Id
          BG002
          value
          216
        title
        Refractory to Lenalidomide
      2. measurements
        1. group Id
          BG000
          value
          18
        2. group Id
          BG001
          value
          17
        3. group Id
          BG002
          value
          35
        title
        Sensitive to Lenalidomide
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease Status (Refractory vs. Sensitive to Lenalidomide)
    unit Of Measure
    Participants
population Description
The analysis population included all randomized participants.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice