NCT01801436 · OUTCOME

Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUC[0-t]) of Bortezomib on Day 11 of Cycle 1

A Post-Approval Pharmacokinetic Study of Bortezomib in Participants With Multiple Myeloma · Source last updated 2013-05-16

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

Measure: MEAN
Unit: Hour*ng per mL
Interval / dispersion: Standard Deviation
Time frame: 0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1

What was measured

The AUC(0-t) is area under the plasma concentration-time curve from zero to the last quantifiable concentration determined by the trapezoidal rule.

Analysis population: The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.

Groups in this outcome

Bortezomib

Participants received 1.3 mg per m\^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.

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
Bortezomib	10

Reported measurements

Source class 1

Values in Hour*ng per mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Bortezomib	190.39	55.27	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
55.27
value
190.39

denoms

counts
group Id
OG000
value
10
units
Participants

description

The AUC(0-t) is area under the plasma concentration-time curve from zero to the last quantifiable concentration determined by the trapezoidal rule.

dispersion Type

Standard Deviation

groups

description
Participants received 1.3 mg per m\^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
id
OG000
title
Bortezomib

param Type

MEAN

population Description

The PP population included all the participants who received study medications as per the administration schedule and for whom blood samples were collected at all scheduled time points.

reporting Status

POSTED

time Frame

0 hour (Pre-dose) and 0.08, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours (post-dose) on Day 11 of Cycle 1

title

Area Under the Plasma Concentration-Time Curve From Time Zero to Time at Last Observed Quantifiable Concentration (AUC[0-t]) of Bortezomib on Day 11 of Cycle 1

type

PRIMARY

unit Of Measure

Hour*ng per mL

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice