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NCT01889186 · FLOW

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A Study of the Efficacy of ABT-199 in Subjects With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia With the 17p Deletion · Source last updated 2021-12-16

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

groups
  1. description
    Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
    id
    FG000
    title
    Main Cohort
  2. description
    Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
    id
    FG001
    title
    Safety Expansion Cohort
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        5
      type
      Adverse event- not related to progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        2
      type
      Adverse event- related to progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      COVID-19 logistical restrictions
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Investigator request
    5. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        7
      type
      Progressive disease- Richter's
    6. reasons
      1. group Id
        FG000
        num Subjects
        46
      2. group Id
        FG001
        num Subjects
        17
      type
      Progressive disease per protocol
    7. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Stem cell transplant
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Withdrew consent
    9. reasons
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        15
      type
      Other, not specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        107
      2. group Id
        FG001
        num Subjects
        51
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        107
      2. group Id
        FG001
        num Subjects
        51
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
All treated participants: all participants who received at least one dose of ABT-199 in either the Main Cohort or Safety Expansion Cohort
Complete source fields
groups
  1. description
    Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
    id
    FG000
    title
    Main Cohort
  2. description
    Participants received ABT-199 tablets once daily (QD) orally for up to 68 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
    id
    FG001
    title
    Safety Expansion Cohort
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        5
      type
      Adverse event- not related to progression
    2. reasons
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        2
      type
      Adverse event- related to progression
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      type
      COVID-19 logistical restrictions
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      type
      Investigator request
    5. reasons
      1. group Id
        FG000
        num Subjects
        12
      2. group Id
        FG001
        num Subjects
        7
      type
      Progressive disease- Richter's
    6. reasons
      1. group Id
        FG000
        num Subjects
        46
      2. group Id
        FG001
        num Subjects
        17
      type
      Progressive disease per protocol
    7. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      type
      Stem cell transplant
    8. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        3
      type
      Withdrew consent
    9. reasons
      1. group Id
        FG000
        num Subjects
        18
      2. group Id
        FG001
        num Subjects
        15
      type
      Other, not specified
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        107
      2. group Id
        FG001
        num Subjects
        51
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        107
      2. group Id
        FG001
        num Subjects
        51
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
All treated participants: all participants who received at least one dose of ABT-199 in either the Main Cohort or Safety Expansion Cohort

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice