NCT03846427 · OUTCOME

Number of Participants With Adverse Events

Study of Zanubrutinib (BGB-3111) in Participants With Marginal Zone Lymphoma · 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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)

What was measured

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory tests, physical exams, and vital signs

Analysis population: Safety analysis set is all participants who were enrolled and received at least 1 dose of study drug

Groups in this outcome

Zanubrutinib

Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent

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
Zanubrutinib	68

Reported measurements

At least one TEAE

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Zanubrutinib	68	Not reported	Not reported	Not reported	Not reported

At least one SAE

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Zanubrutinib	30	Not reported	Not reported	Not reported	Not reported

Complete source fields

calculate Pct

false

classes

categories
measurements
group Id
OG000
value
68
title
At least one TEAE
categories
measurements
group Id
OG000
value
30
title
At least one SAE

denoms

counts
group Id
OG000
value
68
units
Participants

description

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory tests, physical exams, and vital signs

groups

description
Zanubrutinib 160 mg (two 80-mg capsules) orally twice daily with or without food until progressive disease, intolerable toxicity, or withdrawal of consent
id
OG000
title
Zanubrutinib

param Type

COUNT_OF_PARTICIPANTS

population Description

Safety analysis set is all participants who were enrolled and received at least 1 dose of study drug

reporting Status

POSTED

time Frame

From first dose to 30 days after last dose of study drug (Up to approximately 3 years and 2.5 months)

title

Number of Participants With Adverse Events

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice