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NCT02159365 · FLOW

Participant flow

Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients · Source last updated 2019-07-16

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

groups
  1. description
    E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.
    id
    FG000
    title
    E-Ld
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        23
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Other reasons
    3. reasons
      1. group Id
        FG000
        num Subjects
        9
      type
      Administrative reason by Sponsor
    4. reasons
      1. group Id
        FG000
        num Subjects
        9
      type
      Adverse Event unrelated to study drug
    5. reasons
      1. group Id
        FG000
        num Subjects
        7
      type
      Study drug toxicity
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Maximum clinical benefit
    7. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Subject request to discontinue treatment
    8. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Subject withdrew consent
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    10. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        70
      type
      STARTED
    2. achievements
      1. comment
        Completed = Still on treatment
        group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        70
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
84 participants were enrolled. 70 participants were randomized and treated. Reasons for non-randomization/non-treatment were 10 no longer met study criteria, 1 withdrew consent, and 3 due to other reasons.
Complete source fields
groups
  1. description
    E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.
    id
    FG000
    title
    E-Ld
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        23
      type
      Disease Progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        11
      type
      Other reasons
    3. reasons
      1. group Id
        FG000
        num Subjects
        9
      type
      Administrative reason by Sponsor
    4. reasons
      1. group Id
        FG000
        num Subjects
        9
      type
      Adverse Event unrelated to study drug
    5. reasons
      1. group Id
        FG000
        num Subjects
        7
      type
      Study drug toxicity
    6. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Maximum clinical benefit
    7. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Subject request to discontinue treatment
    8. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Subject withdrew consent
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    10. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        70
      type
      STARTED
    2. achievements
      1. comment
        Completed = Still on treatment
        group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        70
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
84 participants were enrolled. 70 participants were randomized and treated. Reasons for non-randomization/non-treatment were 10 no longer met study criteria, 1 withdrew consent, and 3 due to other reasons.

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

Preserved source evidence · Not medical advice