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NCT01698801 · BASELINE

Baseline characteristics

A Phase 2 Study of Lenalidomide to Evaluate the Efficacy in Japanese Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2018-11-08

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
      26
    units
    Participants
groups
  1. description
    Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason. Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.
    id
    BG000
    title
    Lenalidomide Plus Dexamethasone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.01
          value
          74.2
    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
          14
      title
      ≤ 75 Years Old
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      > 75 Years Old
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          13
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Stage III
    description
    The International Staging System (ISS) 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
    Multiple Myeloma Stage before Study Entry
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      0 = Fully Active
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      1= Restrictive but Ambulatory
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      2 = Ambulatory but Unable to Work
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      3 = Limited Self-Care
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      4 = Completely Disabled
    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. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity)
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    participants
population Description
The intent-to-treat (ITT) population consisted of all participants enrolled independent of whether they received study treatment or not.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      26
    units
    Participants
groups
  1. description
    Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason. Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.
    id
    BG000
    title
    Lenalidomide Plus Dexamethasone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          7.01
          value
          74.2
    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
          14
      title
      ≤ 75 Years Old
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          12
      title
      > 75 Years Old
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          13
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      Stage I
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          14
      title
      Stage II
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          5
      title
      Stage III
    description
    The International Staging System (ISS) 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
    Multiple Myeloma Stage before Study Entry
    unit Of Measure
    participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          13
      title
      0 = Fully Active
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      1= Restrictive but Ambulatory
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          6
      title
      2 = Ambulatory but Unable to Work
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      3 = Limited Self-Care
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          0
      title
      4 = Completely Disabled
    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. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity)
    param Type
    NUMBER
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    participants
population Description
The intent-to-treat (ITT) population consisted of all participants enrolled independent of whether they received study treatment or not.

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

Preserved source evidence · Not medical advice