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NCT00424047 · BASELINE

Baseline characteristics

A Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma · Source last updated 2017-10-19

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
      176
    2. group Id
      BG001
      value
      175
    3. group Id
      BG002
      value
      351
    units
    Participants
groups
  1. description
    Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.
    id
    BG000
    title
    Lenalidomide Plus Dexamethasone
  2. description
    Placebo PO daily on Days 1 to 28 of each 28 day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.
    id
    BG001
    title
    Placebo Plus Dexamethasone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.12
          value
          62.2
        2. group Id
          BG001
          spread
          8.80
          value
          62.9
        3. group Id
          BG002
          spread
          9.47
          value
          62.6
    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
          72
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          144
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          207
        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
          78
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          143
      title
      0 = (Fully Active)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          72
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          151
      title
      1 = (Restrictive but Ambulatory)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          50
      title
      2 = Ambulatory unable to Work)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      3 = (Limited Self-Care)
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      4 = (Completely Disabled)
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
      title
      Missing
    description
    Eastern Cooperative Oncology Group (ECOG) Performance Status is used by doctors and researchers to assess how a participants' disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group Performance Status
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          113
      title
      1 Prior anti-myeloma therapy
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          120
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          238
      title
      2 or more prior anti-myeloma therapies
    param Type
    NUMBER
    title
    Number of Prior Anti-Myeloma Therapies
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.4
          upper Limit
          15.7
          value
          3.4
        2. group Id
          BG001
          lower Limit
          0.3
          upper Limit
          26.6
          value
          4.0
        3. group Id
          BG002
          lower Limit
          0.3
          upper Limit
          26.6
          value
          3.7
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time from First Pathological Diagnosis
    unit Of Measure
    years
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          19
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          107
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          110
        3. group Id
          BG002
          value
          225
      title
      Stage III
    description
    The International Staging System divides myeloma into 3 stages based only on the serum beta-2 microglobulin and serum albumin levels. Stage I: Serum beta-2 microglobulin is less than 3.5 (mg/L) and the albumin level is above 3.5 (g/L); Stage II: Neither stage I or III, meaning that either: * The beta-2 microglobulin level is between 3.5 and 5.5 (with any albumin level), OR * The albumin is below 3.5 while the beta-2 microglobulin is less than 3.5 Stage III: Serum beta-2 microglobulin is greater than 5.5.
    param Type
    NUMBER
    title
    Baseline multiple myeloma stage
    unit Of Measure
    participants
population Description
Intent to treat population included all participants who were randomized
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      176
    2. group Id
      BG001
      value
      175
    3. group Id
      BG002
      value
      351
    units
    Participants
groups
  1. description
    Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles.
    id
    BG000
    title
    Lenalidomide Plus Dexamethasone
  2. description
    Placebo PO daily on Days 1 to 28 of each 28 day cycle. Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.
    id
    BG001
    title
    Placebo Plus Dexamethasone
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          10.12
          value
          62.2
        2. group Id
          BG001
          spread
          8.80
          value
          62.9
        3. group Id
          BG002
          spread
          9.47
          value
          62.6
    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
          72
        2. group Id
          BG001
          value
          72
        3. group Id
          BG002
          value
          144
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          104
        2. group Id
          BG001
          value
          103
        3. group Id
          BG002
          value
          207
        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
          78
        2. group Id
          BG001
          value
          65
        3. group Id
          BG002
          value
          143
      title
      0 = (Fully Active)
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          72
        2. group Id
          BG001
          value
          79
        3. group Id
          BG002
          value
          151
      title
      1 = (Restrictive but Ambulatory)
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          23
        2. group Id
          BG001
          value
          27
        3. group Id
          BG002
          value
          50
      title
      2 = Ambulatory unable to Work)
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
      title
      3 = (Limited Self-Care)
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
      title
      4 = (Completely Disabled)
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          6
      title
      Missing
    description
    Eastern Cooperative Oncology Group (ECOG) Performance Status is used by doctors and researchers to assess how a participants' disease is progressing, assess how the disease affects the daily living activities of the participant and determine appropriate treatment and prognosis.
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group Performance Status
    unit Of Measure
    participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          56
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          113
      title
      1 Prior anti-myeloma therapy
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          120
        2. group Id
          BG001
          value
          118
        3. group Id
          BG002
          value
          238
      title
      2 or more prior anti-myeloma therapies
    param Type
    NUMBER
    title
    Number of Prior Anti-Myeloma Therapies
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          0.4
          upper Limit
          15.7
          value
          3.4
        2. group Id
          BG001
          lower Limit
          0.3
          upper Limit
          26.6
          value
          4.0
        3. group Id
          BG002
          lower Limit
          0.3
          upper Limit
          26.6
          value
          3.7
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Time from First Pathological Diagnosis
    unit Of Measure
    years
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          11
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          19
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          50
        2. group Id
          BG001
          value
          57
        3. group Id
          BG002
          value
          107
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          115
        2. group Id
          BG001
          value
          110
        3. group Id
          BG002
          value
          225
      title
      Stage III
    description
    The International Staging System divides myeloma into 3 stages based only on the serum beta-2 microglobulin and serum albumin levels. Stage I: Serum beta-2 microglobulin is less than 3.5 (mg/L) and the albumin level is above 3.5 (g/L); Stage II: Neither stage I or III, meaning that either: * The beta-2 microglobulin level is between 3.5 and 5.5 (with any albumin level), OR * The albumin is below 3.5 while the beta-2 microglobulin is less than 3.5 Stage III: Serum beta-2 microglobulin is greater than 5.5.
    param Type
    NUMBER
    title
    Baseline multiple myeloma stage
    unit Of Measure
    participants
population Description
Intent to treat population included all participants who were randomized

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Preserved source evidence · Not medical advice