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NCT03332173 · OUTCOME

Number of Participants With Adverse Events

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to approximately 3 years and 5 months

What was measured

Number of participants with treatment-emergent adverse events (TEAEs), grade 3 or higher TEAEs, serious adverse events (SAEs), treatment-related adverse events (AEs), adverse events of special interest, and TEAEs leading to study drug discontinuation, dose reduction and treatment interruption

Analysis population: The Safety Analysis Set included all participants who received ≥ 1 dose of study drug

Groups in this outcome

Zanubrutinib

Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Zanubrutinib44

Reported measurements

At least one TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Zanubrutinib44Not reportedNot reportedNot reportedNot reported
Grade 3 or higher TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Zanubrutinib34Not reportedNot reportedNot reportedNot reported
Serious TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Zanubrutinib25Not reportedNot reportedNot reportedNot reported
Treatment-related TEAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Zanubrutinib41Not reportedNot reportedNot reportedNot reported
TEAEs of special interest
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Zanubrutinib43Not reportedNot reportedNot reportedNot reported
TEAEs leading to study drug discontinuation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Zanubrutinib5Not reportedNot reportedNot reportedNot reported
TEAEs leading to treatment interruption
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Zanubrutinib17Not reportedNot reportedNot reportedNot reported
TEAEs leading to dose reduction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Zanubrutinib1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        44
    title
    At least one TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        34
    title
    Grade 3 or higher TEAEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        25
    title
    Serious TEAEs
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        41
    title
    Treatment-related TEAEs
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        43
    title
    TEAEs of special interest
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    TEAEs leading to study drug discontinuation
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        17
    title
    TEAEs leading to treatment interruption
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    TEAEs leading to dose reduction
denoms
  1. counts
    1. group Id
      OG000
      value
      44
    units
    Participants
description
Number of participants with treatment-emergent adverse events (TEAEs), grade 3 or higher TEAEs, serious adverse events (SAEs), treatment-related adverse events (AEs), adverse events of special interest, and TEAEs leading to study drug discontinuation, dose reduction and treatment interruption
groups
  1. description
    Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity
    id
    OG000
    title
    Zanubrutinib
param Type
COUNT_OF_PARTICIPANTS
population Description
The Safety Analysis Set included all participants who received ≥ 1 dose of study drug
reporting Status
POSTED
time Frame
Up to approximately 3 years and 5 months
title
Number of Participants With Adverse Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice