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NCT03846427 · OUTCOME

Duration of Response (DOR) by Investigator Assessment

Study of Zanubrutinib (BGB-3111) in Participants With Marginal Zone Lymphoma · 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
Full Range
Time frame
Up to approximately 3 years and 2.5 months

What was measured

DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the investigator using Lugano Classification.

Analysis population: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug; DOR was summarized for responders only, defined as participants with a best overall response of partial response or above.

Groups in this outcome

Zanubrutinib

Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent

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

Analysis denominator · Participants

GroupSource count
Zanubrutinib50

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
ZanubrutinibNANot reported22.1NANot estimable due to insufficient number of participants with events
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not estimable due to insufficient number of participants with events
        group Id
        OG000
        lower Limit
        22.1
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    units
    Participants
description
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the investigator using Lugano Classification.
dispersion Type
Full Range
groups
  1. description
    Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
    id
    OG000
    title
    Zanubrutinib
param Type
MEDIAN
population Description
Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug; DOR was summarized for responders only, defined as participants with a best overall response of partial response or above.
reporting Status
POSTED
time Frame
Up to approximately 3 years and 2.5 months
title
Duration of Response (DOR) by Investigator Assessment
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice