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NCT00928486 · BASELINE

Baseline characteristics

A Safety Confirmation Study on Lenalidomide With Dexamethasone In Japanese Patients With Previously Treated Multiple Myeloma · Source last updated 2019-11-20

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
      25
    units
    Participants
groups
  1. description
    Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance \<60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
    id
    BG000
    title
    Lenalidomide and Dexamethasone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.99
          value
          62.1
    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
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          12
        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
      title
      Japan
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Safety Population = includes all participants who received at least one dose of study drug
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      25
    units
    Participants
groups
  1. description
    Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance \<60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
    id
    BG000
    title
    Lenalidomide and Dexamethasone
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          9.99
          value
          62.1
    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
          13
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          12
        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
      title
      Japan
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Safety Population = includes all participants who received at least one dose of study drug

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

Preserved source evidence · Not medical advice