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NCT01801436 · OUTCOME

Maximum Observed Plasma Concentration (Cmax) 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
Nanogram per millileter (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 Cmax is observed maximum plasma concentration, taken directly from the plasma concentration-time profile.

Analysis population: The Per-protocol (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 Nanogram per millileter (ng per ml) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Bortezomib76.4338.47Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        38.47
        value
        76.43
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
The Cmax is observed maximum plasma concentration, taken directly from the plasma concentration-time profile.
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
The Per-protocol (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
Maximum Observed Plasma Concentration (Cmax) of Bortezomib on Day 1 of Cycle 1
type
PRIMARY
unit Of Measure
Nanogram per millileter (ng per ml)

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

Preserved source evidence · Not medical advice