NCT03053440 · OUTCOME

DOR as Assessed by the Investigator: 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: 24,36 and 48 months from the date of randomization (up to approximately 5 years and 5 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

Group	Source count
Arm A: Ibrutinib	99
Arm B: Zanubrutinib	102

Reported measurements

24 Months

Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm A: Ibrutinib	87.7	Not reported	77.8	93.4	Not reported
Arm B: Zanubrutinib	89.7	Not reported	80.4	94.7	Not reported

36 Months

Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm A: Ibrutinib	77.5	Not reported	65.9	85.6	Not reported
Arm B: Zanubrutinib	81.1	Not reported	70.1	88.4	Not reported

48 Months

Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Arm A: Ibrutinib	73.9	Not reported	61.6	82.8	Not reported
Arm B: Zanubrutinib	81.1	Not reported	70.1	88.4	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
77.8
upper Limit
93.4
value
87.7
group Id
OG001
lower Limit
80.4
upper Limit
94.7
value
89.7
title
24 Months
categories
measurements
group Id
OG000
lower Limit
65.9
upper Limit
85.6
value
77.5
group Id
OG001
lower Limit
70.1
upper Limit
88.4
value
81.1
title
36 Months
categories
measurements
group Id
OG000
lower Limit
61.6
upper Limit
82.8
value
73.9
group Id
OG001
lower Limit
70.1
upper Limit
88.4
value
81.1
title
48 Months

denoms

counts
group Id
OG000
value
99
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

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
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

24,36 and 48 months from the date of randomization (up to approximately 5 years and 5 months)

title

DOR as Assessed by the Investigator: 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