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NCT03332173 · OUTCOME

Duration of Major Response (DOMR)

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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 1 year and 9 months

What was measured

DOMR is defined as the time from the date that the major response criteria are first met to the date that progressive disease (PD) is objectively documented or death, whichever comes first, as assessed by an independent review committee using modified Owen's criteria

Analysis population: Efficacy Analysis Set includes participants with confirmed Waldenström's macroglobulinemia based on central pathologic review among those who received at least one dose of study drug and with a baseline IgM (or M-protein) ≥ 5 g/L

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
Zanubrutinib43

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
ZanubrutinibNANot reported13.77NANA = not estimable, could not be calculated due insufficient number participants with events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA = not estimable, could not be calculated due insufficient number participants with events
        group Id
        OG000
        lower Limit
        13.77
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      43
    units
    Participants
description
DOMR is defined as the time from the date that the major response criteria are first met to the date that progressive disease (PD) is objectively documented or death, whichever comes first, as assessed by an independent review committee using modified Owen's criteria
dispersion Type
95% Confidence Interval
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
MEDIAN
population Description
Efficacy Analysis Set includes participants with confirmed Waldenström's macroglobulinemia based on central pathologic review among those who received at least one dose of study drug and with a baseline IgM (or M-protein) ≥ 5 g/L
reporting Status
POSTED
time Frame
Up to approximately 1 year and 9 months
title
Duration of Major Response (DOMR)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice