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NCT01023308 · FLOW

Participant flow

Panobinostat or Placebo With Bortezomib and Dexamethasone in Patients With Relapsed Multiple Myeloma · Source last updated 2020-03-17

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

groups
  1. description
    Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
    id
    FG000
    title
    Panobinostat + Bortezomib
  2. description
    Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
    id
    FG001
    title
    Placebo + Bortezomib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        8
      type
      Abnormal test proceedure results
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Administrative problems
    3. reasons
      1. group Id
        FG000
        num Subjects
        130
      2. group Id
        FG001
        num Subjects
        66
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        17
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        82
      2. group Id
        FG001
        num Subjects
        153
      type
      Disease progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        7
      type
      New Cancer therapy
    7. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      type
      Protocol Violation
    8. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        5
      type
      Untreated
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    10. reasons
      1. group Id
        FG000
        num Subjects
        34
      2. group Id
        FG001
        num Subjects
        18
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        387
      2. group Id
        FG001
        num Subjects
        381
      type
      STARTED
    2. achievements
      1. comment
        completed all planned cycles of study treatment as per protocol
        group Id
        FG000
        num Subjects
        102
      2. comment
        completed all planned cycles of study treatment as per protocol
        group Id
        FG001
        num Subjects
        102
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        285
      2. group Id
        FG001
        num Subjects
        279
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
    id
    FG000
    title
    Panobinostat + Bortezomib
  2. description
    Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
    id
    FG001
    title
    Placebo + Bortezomib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        8
      type
      Abnormal test proceedure results
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Administrative problems
    3. reasons
      1. group Id
        FG000
        num Subjects
        130
      2. group Id
        FG001
        num Subjects
        66
      type
      Adverse Event
    4. reasons
      1. group Id
        FG000
        num Subjects
        21
      2. group Id
        FG001
        num Subjects
        17
      type
      Death
    5. reasons
      1. group Id
        FG000
        num Subjects
        82
      2. group Id
        FG001
        num Subjects
        153
      type
      Disease progression
    6. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        7
      type
      New Cancer therapy
    7. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        4
      type
      Protocol Violation
    8. reasons
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        5
      type
      Untreated
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      Lost to Follow-up
    10. reasons
      1. group Id
        FG000
        num Subjects
        34
      2. group Id
        FG001
        num Subjects
        18
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        387
      2. group Id
        FG001
        num Subjects
        381
      type
      STARTED
    2. achievements
      1. comment
        completed all planned cycles of study treatment as per protocol
        group Id
        FG000
        num Subjects
        102
      2. comment
        completed all planned cycles of study treatment as per protocol
        group Id
        FG001
        num Subjects
        102
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        285
      2. group Id
        FG001
        num Subjects
        279
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice