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NCT00985959 · OUTCOME

Maximum Observed Plasma Concentration (Cmax) of Melphalan - Phase I

A Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT) · Source last updated 2013-12-02

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

Measure
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Day 4 of Cycle 2

What was measured

Cmax of melphalan at dose of 9 mg/m2 on Cycle 2/Day 4

Analysis population: Pharmacokinetics-evaluable population: 14 participants were included in pharmacokinetics-evaluable population during Cycle 2

Groups in this outcome

Melphalan

Melphalan 9 mg/m2 on day 1, 2, 3 and 4 of 6-week cycle up to 9 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
Melphalan14

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Melphalan100.249.515Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        49.515
        value
        100.2
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    units
    Participants
description
Cmax of melphalan at dose of 9 mg/m2 on Cycle 2/Day 4
dispersion Type
Standard Deviation
groups
  1. description
    Melphalan 9 mg/m2 on day 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
    id
    OG000
    title
    Melphalan
param Type
MEAN
population Description
Pharmacokinetics-evaluable population: 14 participants were included in pharmacokinetics-evaluable population during Cycle 2
reporting Status
POSTED
time Frame
Day 4 of Cycle 2
title
Maximum Observed Plasma Concentration (Cmax) of Melphalan - Phase I
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice