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NCT03846427 · OUTCOME

TTR by IRC 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
95% Confidence Interval
Time frame
Up to approximately 3 years and 2.5 months

What was measured

TTR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better), as assessed by the IRC 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; TTR 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
Zanubrutinib45

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Zanubrutinib2.79Not reported1.711.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.7
        upper Limit
        11.1
        value
        2.79
denoms
  1. counts
    1. group Id
      OG000
      value
      45
    units
    Participants
description
TTR is defined as the time from study treatment start to date of the earliest qualifying response (partial response or better), as assessed by the IRC using Lugano Classification.
dispersion Type
95% Confidence Interval
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; TTR 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
TTR by IRC Assessment
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice