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NCT03053440 · OUTCOME

DOR as Assessed by IRC: Event -Free Rate

A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström's Macroglobulinemia (WM) · 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
12 and 18 months from the date of randomization (up to approximately 2 years and 7 months)

What was measured

Estimated percentage of participants who were event-free based on Kaplan-Meier method.

Analysis population: ITT Analysis Set

Groups in this outcome

Arm A: Ibrutinib

Participants diagnosed with WM with mutated MYD88 gene received 420 mg ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor

Arm B: Zanubrutinib

Participants diagnosed with WM with mutated MYD88 gene received 160 mg zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor

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

Analysis denominator · Participants

GroupSource count
Arm A: Ibrutinib99
Arm B: Zanubrutinib102

Reported measurements

12 Months
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Ibrutinib87.9Not reported77.093.8Not reported
Arm B: Zanubrutinib94.4Not reported85.897.9Not reported
18 Months
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Ibrutinib87.9Not reported77.093.8Not reported
Arm B: Zanubrutinib85.2Not reported71.792.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        77.0
        upper Limit
        93.8
        value
        87.9
      2. group Id
        OG001
        lower Limit
        85.8
        upper Limit
        97.9
        value
        94.4
    title
    12 Months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        77.0
        upper Limit
        93.8
        value
        87.9
      2. group Id
        OG001
        lower Limit
        71.7
        upper Limit
        92.6
        value
        85.2
    title
    18 Months
denoms
  1. counts
    1. group Id
      OG000
      value
      99
    2. group Id
      OG001
      value
      102
    units
    Participants
description
Estimated percentage of participants who were event-free based on Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants diagnosed with WM with mutated MYD88 gene received 420 mg ibrutinib once daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
    id
    OG000
    title
    Arm A: Ibrutinib
  2. description
    Participants diagnosed with WM with mutated MYD88 gene received 160 mg zanubrutinib twice daily orally until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
    id
    OG001
    title
    Arm B: Zanubrutinib
param Type
NUMBER
population Description
ITT Analysis Set
reporting Status
POSTED
time Frame
12 and 18 months from the date of randomization (up to approximately 2 years and 7 months)
title
DOR as Assessed by IRC: 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