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NCT03053440 · OUTCOME

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

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
Number of Participants
Interval / dispersion
Not reported
Time frame
Up to approximately 5 years and 5 months

Analysis population: Safety Analysis Set includes all participants who received any dose of zanubrutinib or ibrutinib

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: Ibrutinib98
Arm B: Zanubrutinib101

Reported measurements

Participants with At Least 1 TEAE
Values in Number of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Ibrutinib98Not reportedNot reportedNot reportedNot reported
Arm B: Zanubrutinib101Not reportedNot reportedNot reportedNot reported
Participants with SAEs
Values in Number of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Ibrutinib50Not reportedNot reportedNot reportedNot reported
Arm B: Zanubrutinib59Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        98
      2. group Id
        OG001
        value
        101
    title
    Participants with At Least 1 TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        50
      2. group Id
        OG001
        value
        59
    title
    Participants with SAEs
denoms
  1. counts
    1. group Id
      OG000
      value
      98
    2. group Id
      OG001
      value
      101
    units
    Participants
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
Safety Analysis Set includes all participants who received any dose of zanubrutinib or ibrutinib
reporting Status
POSTED
time Frame
Up to approximately 5 years and 5 months
title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
type
SECONDARY
unit Of Measure
Number of Participants

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

Preserved source evidence · Not medical advice