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NCT00420849 · FLOW

Participant flow

A Multicentre, Single-arm, Open-label Safety Study of Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma · Source last updated 2012-05-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
    id
    FG000
    title
    Lenalidomide Plus Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        154
      type
      Lack of Efficacy
    2. reasons
      1. group Id
        FG000
        num Subjects
        107
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        28
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        18
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        14
      type
      Other
    6. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Transplant
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Protocol Violation
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        587
      type
      STARTED
    2. achievements
      1. comment
        Participants completed the study upon commercial availability of lenalidomide
        group Id
        FG000
        num Subjects
        256
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        331
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
    id
    FG000
    title
    Lenalidomide Plus Dexamethasone
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        154
      type
      Lack of Efficacy
    2. reasons
      1. group Id
        FG000
        num Subjects
        107
      type
      Adverse Event
    3. reasons
      1. group Id
        FG000
        num Subjects
        28
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        18
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        14
      type
      Other
    6. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Transplant
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Protocol Violation
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        587
      type
      STARTED
    2. achievements
      1. comment
        Participants completed the study upon commercial availability of lenalidomide
        group Id
        FG000
        num Subjects
        256
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        331
      type
      NOT COMPLETED
    title
    Overall Study

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

Preserved source evidence · Not medical advice