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NCT03053440 · OUTCOME

Percentage of Participants With an Anti-Lymphoma Effect

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
Not reported
Time frame
Up to approximately 5 years and 5 months

What was measured

Anti-Lymphoma Effect is defined as any reduction in bone marrow involvement by lymphoplasmacytoid lymphocytes and/or size of lymphadenopathy and/or splenomegaly by CT scan, at any time during the course of study treatment.

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: Not reported
GroupValueSpreadLowerUpperComment
Arm A: Ibrutinib84.2Not reportedNot reportedNot reportedNot reported
Arm B: Zanubrutinib78.8Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        84.2
      2. group Id
        OG001
        value
        78.8
denoms
  1. counts
    1. group Id
      OG000
      value
      99
    2. group Id
      OG001
      value
      102
    units
    Participants
description
Anti-Lymphoma Effect is defined as any reduction in bone marrow involvement by lymphoplasmacytoid lymphocytes and/or size of lymphadenopathy and/or splenomegaly by CT scan, at any time during the course of study treatment.
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 With an Anti-Lymphoma Effect
type
SECONDARY
unit Of Measure
Percentage of Participants

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

Preserved source evidence · Not medical advice