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NCT03029234 · BASELINE

Baseline characteristics

Carfilzomib in Combination With Dexamethasone (Kd) in Chinese Patients With Relapsed & Refractory Multiple Myeloma · Source last updated 2022-05-25

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
      123
    units
    Participants
groups
  1. description
    Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants also received 20 mg dexamethasone IV or orally on days 1, 2, 8, 9, 15, 16, 22, and 23. Participants received treatment until disease progression, unacceptable toxicity, initiation of new antimyeloma therapy, withdrawal of consent, subject noncompliance, or intercurrent illness or worsening of a chronic condition, whichever occurred first.
    id
    BG000
    title
    Carfilzomib With Dexamethasone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.4
          value
          59.8
      denoms
      1. counts
        1. group Id
          BG000
          value
          123
        units
        Participants
    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
          56
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          67
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          123
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          123
        title
        Asian
      denoms
      1. counts
        1. group Id
          BG000
          value
          123
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          68
        title
        0 (Fully active)
      2. measurements
        1. group Id
          BG000
          value
          45
        title
        1 (Restricted but ambulatory)
      3. measurements
        1. group Id
          BG000
          value
          10
        title
        2 (Ambulatory but unable to work)
      denoms
      1. counts
        1. group Id
          BG000
          value
          123
        units
        Participants
    description
    A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care, unable to carry out any work activities. Up and about \> 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.4
          upper Limit
          182.8
          value
          38.70
      denoms
      1. counts
        1. group Id
          BG000
          value
          117
        units
        Participants
    description
    One participant had a data entry error with year of diagnosis entered as 2017 instead of 2014, leading to an erroneous minimum time since diagnosis reported.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Participants with available data
    title
    Time From Initial Diagnosis to First Dose
    unit Of Measure
    months
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2
          upper Limit
          19
          value
          4.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          123
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Total Number of Prior Regimens
    unit Of Measure
    regimens
population Description
The safety population consisted of all enrolled participants who received at least 1 dose of carfilzomib.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      123
    units
    Participants
groups
  1. description
    Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter). Participants also received 20 mg dexamethasone IV or orally on days 1, 2, 8, 9, 15, 16, 22, and 23. Participants received treatment until disease progression, unacceptable toxicity, initiation of new antimyeloma therapy, withdrawal of consent, subject noncompliance, or intercurrent illness or worsening of a chronic condition, whichever occurred first.
    id
    BG000
    title
    Carfilzomib With Dexamethasone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.4
          value
          59.8
      denoms
      1. counts
        1. group Id
          BG000
          value
          123
        units
        Participants
    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
          56
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          67
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          123
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          123
        title
        Asian
      denoms
      1. counts
        1. group Id
          BG000
          value
          123
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          68
        title
        0 (Fully active)
      2. measurements
        1. group Id
          BG000
          value
          45
        title
        1 (Restricted but ambulatory)
      3. measurements
        1. group Id
          BG000
          value
          10
        title
        2 (Ambulatory but unable to work)
      denoms
      1. counts
        1. group Id
          BG000
          value
          123
        units
        Participants
    description
    A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care, unable to carry out any work activities. Up and about \> 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair \> 50% of waking hours; 4 = Completely disabled, confined to bed or chair; 5 = Dead.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.4
          upper Limit
          182.8
          value
          38.70
      denoms
      1. counts
        1. group Id
          BG000
          value
          117
        units
        Participants
    description
    One participant had a data entry error with year of diagnosis entered as 2017 instead of 2014, leading to an erroneous minimum time since diagnosis reported.
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    population Description
    Participants with available data
    title
    Time From Initial Diagnosis to First Dose
    unit Of Measure
    months
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          2
          upper Limit
          19
          value
          4.0
      denoms
      1. counts
        1. group Id
          BG000
          value
          123
        units
        Participants
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Total Number of Prior Regimens
    unit Of Measure
    regimens
population Description
The safety population consisted of all enrolled participants who received at least 1 dose of carfilzomib.

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

Preserved source evidence · Not medical advice