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NCT03206970 · FLOW

Participant flow

Study to Evaluate Efficacy and Safety of BGB-3111 in Participants With Relapsed or Refractory Mantle Cell Lymphoma (MCL) · 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 milligrams \[mg\]) administered orally twice daily (BID) until disease progression, unacceptable toxicity or death, withdrawal of consent, lost to follow up, or study termination by sponsor, which comes first.
    id
    FG000
    title
    Zanubrutinib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        21
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        13
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        49
      type
      Primary and secondary objectives were met and remaining participants transferred to LTE by sponsor
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        86
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        86
      comment
      Safety Analysis Set
      type
      Received at Least 1 Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        86
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
This study was conducted at 14 study centers in China; 13 study centers enrolled participants. Once the primary and secondary objectives were met and the analysis was complete, sponsor ended the study on 08 September 2020 and transferred all participants remaining on treatment to long term extension study.
Complete source fields
groups
  1. description
    Zanubrutinib (160 milligrams \[mg\]) administered orally twice daily (BID) until disease progression, unacceptable toxicity or death, withdrawal of consent, lost to follow up, or study termination by sponsor, which comes first.
    id
    FG000
    title
    Zanubrutinib
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        21
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        13
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        49
      type
      Primary and secondary objectives were met and remaining participants transferred to LTE by sponsor
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        86
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        86
      comment
      Safety Analysis Set
      type
      Received at Least 1 Dose of Study Drug
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      type
      COMPLETED
    4. achievements
      1. group Id
        FG000
        num Subjects
        86
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
This study was conducted at 14 study centers in China; 13 study centers enrolled participants. Once the primary and secondary objectives were met and the analysis was complete, sponsor ended the study on 08 September 2020 and transferred all participants remaining on treatment to long term extension study.

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Preserved source evidence · Not medical advice