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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 1 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 1 of Cycle 1

What was measured

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

Analysis population: 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

GroupSource count
Bortezomib10

Reported measurements

Source class 1
Values in Hour*ng per ml · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bortezomib51.8630.56Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.56
        value
        51.86
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
The AUC(0-t) is area under the plasma concentration-time curve from time zero to the last quantifiable concentration determined by the trapezoidal rule.
dispersion Type
Standard Deviation
groups
  1. 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
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 1 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 1 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