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NCT03332173 · FLOW

Participant flow

Study of BTK Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström's Macroglobulinemia (WM) · Source last updated 2024-10-26

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

groups
  1. description
    Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity
    id
    FG000
    title
    Zanubrutinib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        7
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        29
      type
      Transferred to long-term extension study
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        44
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        44
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The protocol-defined efficacy analyses were performed 12 months after the last patient received the first dose of study drug, with a data cutoff date of 08 May 2019.
recruitment Details
This study enrolled participants at 10 study centers in China. The first participant was dosed on 31 August 2017, and the last participant enrolled and received their first dose of zanubrutinib on 08 May 2018. A total of 44 participants were enrolled and all received at least 1 dose of the study drug.
Complete source fields
groups
  1. description
    Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity
    id
    FG000
    title
    Zanubrutinib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        7
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        6
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        29
      type
      Transferred to long-term extension study
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        44
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        44
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The protocol-defined efficacy analyses were performed 12 months after the last patient received the first dose of study drug, with a data cutoff date of 08 May 2019.
recruitment Details
This study enrolled participants at 10 study centers in China. The first participant was dosed on 31 August 2017, and the last participant enrolled and received their first dose of zanubrutinib on 08 May 2018. A total of 44 participants were enrolled and all received at least 1 dose of the study drug.

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

Preserved source evidence · Not medical advice