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NCT01282424 · FLOW

Participant flow

Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas · Source last updated 2019-07-11

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

groups
  1. description
    Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
    id
    FG000
    title
    Idelalisib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        30
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Withdrew Consent
    3. reasons
      1. group Id
        FG000
        num Subjects
        7
      type
      Investigator Request
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Other (Unknown)
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        125
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        70
      type
      Completed: Disease Progression
    3. achievements
      1. group Id
        FG000
        num Subjects
        9
      type
      Completed: Death
    4. achievements
      1. group Id
        FG000
        num Subjects
        79
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        46
      type
      NOT COMPLETED
    title
    Treatment Period (TP) (81 Months)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrew Consent
    2. reasons
      1. group Id
        FG000
        num Subjects
        40
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        21
      type
      Other (Unknown)
    milestones
    1. achievements
      1. comment
        Participants did not have to complete the TP in order to enter the Long-term Follow-up Period.
        group Id
        FG000
        num Subjects
        84
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        20
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        64
      type
      NOT COMPLETED
    title
    Long-term Follow-up Period (5 Years)
pre Assignment Details
125 participants were enrolled and treated and comprise the Intent-to-Treat (ITT) Analysis Set.
recruitment Details
Participants were enrolled at a total of 54 study sites in North America and Europe. The first participant was screened on 04 March 2011. The last participant observation was on 16 May 2018.
Complete source fields
groups
  1. description
    Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
    id
    FG000
    title
    Idelalisib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        30
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Withdrew Consent
    3. reasons
      1. group Id
        FG000
        num Subjects
        7
      type
      Investigator Request
    4. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Other (Unknown)
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        125
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        70
      type
      Completed: Disease Progression
    3. achievements
      1. group Id
        FG000
        num Subjects
        9
      type
      Completed: Death
    4. achievements
      1. group Id
        FG000
        num Subjects
        79
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        46
      type
      NOT COMPLETED
    title
    Treatment Period (TP) (81 Months)
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrew Consent
    2. reasons
      1. group Id
        FG000
        num Subjects
        40
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        21
      type
      Other (Unknown)
    milestones
    1. achievements
      1. comment
        Participants did not have to complete the TP in order to enter the Long-term Follow-up Period.
        group Id
        FG000
        num Subjects
        84
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        20
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        64
      type
      NOT COMPLETED
    title
    Long-term Follow-up Period (5 Years)
pre Assignment Details
125 participants were enrolled and treated and comprise the Intent-to-Treat (ITT) Analysis Set.
recruitment Details
Participants were enrolled at a total of 54 study sites in North America and Europe. The first participant was screened on 04 March 2011. The last participant observation was on 16 May 2018.

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Preserved source evidence · Not medical advice