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NCT03332017 · OUTCOME

Area Under the Curve (AUCss) of Zanubrutinib at Steady State

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
nanogram·hour per milliliter (ng·h/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.

What was measured

Pharmacokinetic exposure parameters were estimated for each participant using a population pharmacokinetic (PK) model.

Analysis population: The PK Analysis Set included all zanubrutinib-treated participants with ≥1 post-baseline PK concentration (n=142). Concentrations were excluded per prespecified rules (missing/invalid times, pre-dose values, peak-trough switches, and outliers), resulting in 137 participants with reported PK parameters.

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

GroupSource count
Zanubrutinib + Obinutuzumab137

Reported measurements

Source class 1
Values in nanogram·hour per milliliter (ng·h/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Zanubrutinib + Obinutuzumab2203.6190211045.430371Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1045.430371
        value
        2203.619021
denoms
  1. counts
    1. group Id
      OG000
      value
      137
    units
    Participants
description
Pharmacokinetic exposure parameters were estimated for each participant using a population pharmacokinetic (PK) model.
dispersion Type
Standard Deviation
groups
  1. 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 PK Analysis Set included all zanubrutinib-treated participants with ≥1 post-baseline PK concentration (n=142). Concentrations were excluded per prespecified rules (missing/invalid times, pre-dose values, peak-trough switches, and outliers), resulting in 137 participants with reported PK parameters.
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
Area Under the Curve (AUCss) of Zanubrutinib at Steady State
type
SECONDARY
unit Of Measure
nanogram·hour per milliliter (ng·h/mL)

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

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