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NCT03846427 · OUTCOME

ORR by IRC Assessment Using Positron Emission Tomography-Computed Tomography (PET-CT)

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 and partial response as the best overall response, as determined by an IRC using PET-CT assessment data for participants with fluorodeoxyglucose (FDG)-avid disease

Analysis population: Efficacy analysis set consisted of evaluable participants with FDG-avid disease at baseline

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
Zanubrutinib59

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Zanubrutinib69.5Not reported56.1380.81Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        56.13
        upper Limit
        80.81
        value
        69.5
denoms
  1. counts
    1. group Id
      OG000
      value
      59
    units
    Participants
description
ORR is defined as the percentage of participants with complete and partial response as the best overall response, as determined by an IRC using PET-CT assessment data for participants with fluorodeoxyglucose (FDG)-avid disease
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 evaluable participants with FDG-avid disease at baseline
reporting Status
POSTED
time Frame
Up to approximately 3 years and 2.5 months
title
ORR by IRC Assessment Using Positron Emission Tomography-Computed Tomography (PET-CT)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice