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NCT03734016 · OUTCOME

Number of Participants With Treatment-emergent Adverse Events (TEAE)

A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia · Source last updated 2025-03-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From first dose of study drug up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.

What was measured

An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose: * Resulted in death * Was life-threatening * Required hospitalization or prolongation of existing hospitalization * Resulted in disability/incapacity * Resulted in a congenital anomaly/birth defect * Was considered a significant medical AE by the investigator based on medical judgment

Analysis population: The Safety Analysis Set includes all participants who received any dose of study drug.

Groups in this outcome

Zanubrutinib

Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.

Ibrutinib

Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.

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

Analysis denominator · Participants

GroupSource count
Zanubrutinib324
Ibrutinib324

Reported measurements

Any TEAE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Zanubrutinib322Not reportedNot reportedNot reportedNot reported
Ibrutinib323Not reportedNot reportedNot reportedNot reported
Serious adverse events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Zanubrutinib172Not reportedNot reportedNot reportedNot reported
Ibrutinib196Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        322
      2. group Id
        OG001
        value
        323
    title
    Any TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        172
      2. group Id
        OG001
        value
        196
    title
    Serious adverse events
denoms
  1. counts
    1. group Id
      OG000
      value
      324
    2. group Id
      OG001
      value
      324
    units
    Participants
description
An adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose: * Resulted in death * Was life-threatening * Required hospitalization or prolongation of existing hospitalization * Resulted in disability/incapacity * Resulted in a congenital anomaly/birth defect * Was considered a significant medical AE by the investigator based on medical judgment
groups
  1. description
    Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
    id
    OG000
    title
    Zanubrutinib
  2. description
    Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
    id
    OG001
    title
    Ibrutinib
param Type
COUNT_OF_PARTICIPANTS
population Description
The Safety Analysis Set includes all participants who received any dose of study drug.
reporting Status
POSTED
time Frame
From first dose of study drug up to 30 days after last dose, up to the end of study data cutoff (28 February 2024); median (range) time on treatment was 41.2 (0.4-59.1) months in the zanubrutinib arm and 37.8 (0.1-60.4) months in the ibrutinib arm.
title
Number of Participants With Treatment-emergent Adverse Events (TEAE)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice