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NCT00928486 · FLOW

Participant flow

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.

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
    FG000
    title
    Lenalidomide and Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      type
      Disease Progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        25
      type
      STARTED
    2. achievements
      1. comment
        EE population = given at least 1 dose of study drug, evaluated for efficacy and met eligibility
        group Id
        FG000
        num Subjects
        24
      type
      Efficacy Evaluable (EE)
    3. achievements
      1. comment
        Completed = those who continued responding to treatment; upon marketing approval, given lenalidomide
        group Id
        FG000
        num Subjects
        15
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
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
    FG000
    title
    Lenalidomide and Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      type
      Disease Progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        25
      type
      STARTED
    2. achievements
      1. comment
        EE population = given at least 1 dose of study drug, evaluated for efficacy and met eligibility
        group Id
        FG000
        num Subjects
        24
      type
      Efficacy Evaluable (EE)
    3. achievements
      1. comment
        Completed = those who continued responding to treatment; upon marketing approval, given lenalidomide
        group Id
        FG000
        num Subjects
        15
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        10
      type
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Not medical advice