Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03846427 · OUTCOME

Overall Response Rate (ORR) by Independent Review Committee (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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately 3 years and 2.5 months

What was measured

ORR is defined as the percentage of participants with complete or partial response as the best overall response, as determined by an IRC using the 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

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
Zanubrutinib68.2Not reported55.5679.11Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    non Inferiority Comment
    P value was based on the exact binomial test against the null hypothesis of ORR = 30% with alternative of ORR \> 30%
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    statistical Method
    Binomial exact method
Complete source fields
analyses
  1. group Ids
    1. OG000
    non Inferiority Comment
    P value was based on the exact binomial test against the null hypothesis of ORR = 30% with alternative of ORR \> 30%
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    statistical Method
    Binomial exact method
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        55.56
        upper Limit
        79.11
        value
        68.2
denoms
  1. counts
    1. group Id
      OG000
      value
      66
    units
    Participants
description
ORR is defined as the percentage of participants with complete or partial response as the best overall response, as determined by an IRC using the 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
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 approximately 3 years and 2.5 months
title
Overall Response Rate (ORR) by Independent Review Committee (IRC) Assessment
type
PRIMARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice