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NCT03110562 · BASELINE

Baseline characteristics

Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma · Source last updated 2024-08-21

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
      195
    2. group Id
      BG001
      value
      207
    3. group Id
      BG002
      value
      402
    units
    Participants
groups
  1. description
    Participants received a fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with SC injection of 1.3 mg/m\^2 bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone BIW on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
    id
    BG000
    title
    SVd Arm: Selinexor + Bortezomib + Dexamethasone
  2. description
    Participants received SC injection of 1.3 mg/m\^2 bortezomib on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by \>= 9 cycles on Days 1, 8, 15, and 22 of each 35-day cycle, and received oral dose of 20 mg dexamethasone BIW on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for the first 8 cycles and for cycles \>= 9 on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
    id
    BG001
    title
    Vd Arm: Bortezomib + Dexamethasone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.56
          value
          65.3
        2. group Id
          BG001
          spread
          9.35
          value
          66.7
        3. group Id
          BG002
          spread
          9.47
          value
          66.0
    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
          80
        2. group Id
          BG001
          value
          92
        3. group Id
          BG002
          value
          172
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          115
        3. group Id
          BG002
          value
          230
        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
          25
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          50
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          11
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          161
        2. group Id
          BG001
          value
          165
        3. group Id
          BG002
          value
          326
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          14
        title
        Missing
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          11
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          188
        3. group Id
          BG002
          value
          359
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          25
        title
        Not Reported
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
        title
        Unknown
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Missing
      title
      Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Intent-to-treat (ITT) population consisted of all participants who were randomized to the study treatment, regardless of whether or not they received the study treatment.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      195
    2. group Id
      BG001
      value
      207
    3. group Id
      BG002
      value
      402
    units
    Participants
groups
  1. description
    Participants received a fixed oral dose of 100 mg selinexor tablets (5 tablets of 20 mg each) QW on Days 1, 8, 15, 22, and 29 of each 35-day cycle, along with SC injection of 1.3 mg/m\^2 bortezomib QW on Days 1, 8, 15, and 22 of each 35-day cycle, and an oral dose of 20 mg of dexamethasone BIW on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
    id
    BG000
    title
    SVd Arm: Selinexor + Bortezomib + Dexamethasone
  2. description
    Participants received SC injection of 1.3 mg/m\^2 bortezomib on Days 1, 4, 8, and 11 of each 21-day cycle for the first 8 cycles, followed by \>= 9 cycles on Days 1, 8, 15, and 22 of each 35-day cycle, and received oral dose of 20 mg dexamethasone BIW on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle for the first 8 cycles and for cycles \>= 9 on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle until PD confirmed by the IRC, investigator or participant decision to discontinue study treatment, pregnancy, unacceptable AEs or toxicity that could not be managed by supportive care, withdrawal of consent, death, or sponsor decision to terminate the study.
    id
    BG001
    title
    Vd Arm: Bortezomib + Dexamethasone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.56
          value
          65.3
        2. group Id
          BG001
          spread
          9.35
          value
          66.7
        3. group Id
          BG002
          spread
          9.47
          value
          66.0
    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
          80
        2. group Id
          BG001
          value
          92
        3. group Id
          BG002
          value
          172
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          115
        3. group Id
          BG002
          value
          230
        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
          25
        2. group Id
          BG001
          value
          25
        3. group Id
          BG002
          value
          50
        title
        Asian
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          11
        title
        Black or African American
      3. measurements
        1. group Id
          BG000
          value
          161
        2. group Id
          BG001
          value
          165
        3. group Id
          BG002
          value
          326
        title
        White
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Other
      5. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          14
        title
        Missing
      title
      Race
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          6
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          11
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          171
        2. group Id
          BG001
          value
          188
        3. group Id
          BG002
          value
          359
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          25
        title
        Not Reported
      4. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          6
        title
        Unknown
      5. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Missing
      title
      Ethnicity
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
population Description
Intent-to-treat (ITT) population consisted of all participants who were randomized to the study treatment, regardless of whether or not they received the study treatment.

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Preserved source evidence · Not medical advice