NCT03332017 · OUTCOME

Zanubrutinib Plasma Concentrations

A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma · Source last updated 2026-02-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: nanograms per milliliter (ng/ml)
Interval / dispersion: Standard Deviation
Time frame: Cycle 1 Day 1 and Cycle 2 Day 1: Predose (within 30 minutes before zanubrutinib dosing) and 2 hours (± 30 minutes) post-dose.

Analysis population: The Pharmacokinetics (PK) Analysis Set included all zanubrutinib-treated participants who had at least one post-baseline PK concentration measurement.

Groups in this outcome

Zanubrutinib + Obinutuzumab

Zanubrutinib 160 mg twice a day orally with or without food; Obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2 to 6; and then every 8 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; each cycle is 28 days

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 + Obinutuzumab	142

Reported measurements

Cycle 1 Day 1 (2h Postdose)

Analysis denominator · Participants

Group	Source count
Zanubrutinib + Obinutuzumab	131

Values in nanograms per milliliter (ng/ml) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Zanubrutinib + Obinutuzumab	254.30	181.783	Not reported	Not reported	Not reported

Cycle 2 Day 1 (Predose)

Analysis denominator · Participants

Group	Source count
Zanubrutinib + Obinutuzumab	112

Values in nanograms per milliliter (ng/ml) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Zanubrutinib + Obinutuzumab	22.29	36.078	Not reported	Not reported	Not reported

Cycle 2 Day 1 (2h Postdose)

Analysis denominator · Participants

Group	Source count
Zanubrutinib + Obinutuzumab	126

Values in nanograms per milliliter (ng/ml) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Zanubrutinib + Obinutuzumab	198.37	138.310	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
181.783
value
254.30
denoms
counts
group Id
OG000
value
131
units
Participants
title
Cycle 1 Day 1 (2h Postdose)
categories
measurements
group Id
OG000
spread
36.078
value
22.29
denoms
counts
group Id
OG000
value
112
units
Participants
title
Cycle 2 Day 1 (Predose)
categories
measurements
group Id
OG000
spread
138.310
value
198.37
denoms
counts
group Id
OG000
value
126
units
Participants
title
Cycle 2 Day 1 (2h Postdose)

denoms

counts
group Id
OG000
value
142
units
Participants

dispersion Type

Standard Deviation

groups

description
Zanubrutinib 160 mg twice a day orally with or without food; Obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2 to 6; and then every 8 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; each cycle is 28 days
id
OG000
title
Zanubrutinib + Obinutuzumab

param Type

MEAN

population Description

The Pharmacokinetics (PK) Analysis Set included all zanubrutinib-treated participants who had at least one post-baseline PK concentration measurement.

reporting Status

POSTED

time Frame

Cycle 1 Day 1 and Cycle 2 Day 1: Predose (within 30 minutes before zanubrutinib dosing) and 2 hours (± 30 minutes) post-dose.

title

Zanubrutinib Plasma Concentrations

type

SECONDARY

unit Of Measure

nanograms per milliliter (ng/ml)

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

Preserved source evidence · Independent clinical review pending · Not medical advice