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NCT03734016 · OUTCOME

Percentage of Participants With Atrial Fibrillation or Atrial Flutter

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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).

What was measured

Participants were considered as having an atrial fibrillation/flutter event if they had a treatment-emergent AE of either "atrial fibrillation" or "atrial flutter".

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

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Zanubrutinib5.2Not reported3.18.3Not reported
Ibrutinib13.3Not reported9.817.5Not reported

Source statistical analyses

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

  1. ci Lower Limit
    -12.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -3.6
    estimate Comment
    Rate difference is the zanubrutinib rate minus the ibrutinib rate.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0004
    param Type
    Rate Difference
    param Value
    -8.0
    statistical Method
    Chi-squared
Complete source fields
analyses
  1. ci Lower Limit
    -12.4
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    -3.6
    estimate Comment
    Rate difference is the zanubrutinib rate minus the ibrutinib rate.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0004
    param Type
    Rate Difference
    param Value
    -8.0
    statistical Method
    Chi-squared
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.1
        upper Limit
        8.3
        value
        5.2
      2. group Id
        OG001
        lower Limit
        9.8
        upper Limit
        17.5
        value
        13.3
denoms
  1. counts
    1. group Id
      OG000
      value
      324
    2. group Id
      OG001
      value
      324
    units
    Participants
description
Participants were considered as having an atrial fibrillation/flutter event if they had a treatment-emergent AE of either "atrial fibrillation" or "atrial flutter".
dispersion Type
95% Confidence Interval
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
NUMBER
population Description
The Safety Analysis Set includes all participants who received any dose of study drug.
reporting Status
POSTED
time Frame
From randomization to the final efficacy analysis cutoff date of 08 August 2022, median time on follow-up was 29.6 months (maximum of 45.2 months).
title
Percentage of Participants With Atrial Fibrillation or Atrial Flutter
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice