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NCT03053440 · OUTCOME

Percentage of Participants Achieving Either CR or VGPR in as Assessed by the Investigator

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
Up to approximately 5 years and 5 months

What was measured

Percentage of participants with CR, defined as normal serum IgM levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at Baseline, or VGPR, defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values.

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

Source class 1
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A: Ibrutinib25.3Not reported17.135.0Not reported
Arm B: Zanubrutinib38.2Not reported28.848.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.1
        upper Limit
        35.0
        value
        25.3
      2. group Id
        OG001
        lower Limit
        28.8
        upper Limit
        48.4
        value
        38.2
denoms
  1. counts
    1. group Id
      OG000
      value
      99
    2. group Id
      OG001
      value
      102
    units
    Participants
description
Percentage of participants with CR, defined as normal serum IgM levels, disappearance of monoclonal protein by immunofixation, and negative cryoglobulinemia if cryoglobulinemia was positive at Baseline, or VGPR, defined as ≥90% reduction in serum IgM level from baseline or normal serum IgM values.
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
Up to approximately 5 years and 5 months
title
Percentage of Participants Achieving Either CR or VGPR in as Assessed by the Investigator
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice