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NCT03846427 · OUTCOME

OS Event-Free Rate

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported

What was measured

OS is defined as the time from first study drug administration to the date of death due to any cause. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for OS at 24 months with 95% confidence intervals estimated using Greenwood's formula.

Analysis population: Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug

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
Zanubrutinib66

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Zanubrutinib85.9Not reported74.792.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        74.7
        upper Limit
        92.4
        value
        85.9
denoms
  1. counts
    1. group Id
      OG000
      value
      66
    units
    Participants
description
OS is defined as the time from first study drug administration to the date of death due to any cause. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for OS at 24 months with 95% confidence intervals estimated using Greenwood's formula.
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
NUMBER
population Description
Efficacy analysis set consisted of all participants with a confirmed diagnosis of MZL who received at least 1 dose of study drug
reporting Status
POSTED
time Frame
Up to 3 years and 2.5 months after first participant enrolled; Month 24 reported
title
OS Event-Free Rate
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice