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NCT02395666 · OUTCOME

Peak Plasma Concentration (Cmax)

Preventative Trial of Difluoromethylornithine (DFMO) in High Risk Patients With Neuroblastoma That is in Remission · Source last updated 2024-08-06

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
90% Confidence Interval
Time frame
Samples drawn at 5 timepoints: (0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose) on two different days

What was measured

Pharmacokinetic assay Cmax/D Samples drawn at 5 timepoints: (0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose) on two different days.

Analysis population: 12 subjects from both Stratum 1 and 2 were analyzed together as one group as per statistical analysis plan.

Groups in this outcome

Study Subjects Consented to PK Collection

Includes study subjects from either stratum that signed an optional consent to have PK's collected

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Study Subjects Consented to PK Collection12

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Study Subjects Consented to PK Collection11958Not reported512318793Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5123
        upper Limit
        18793
        value
        11958
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
Pharmacokinetic assay Cmax/D Samples drawn at 5 timepoints: (0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose) on two different days.
dispersion Type
90% Confidence Interval
groups
  1. description
    Includes study subjects from either stratum that signed an optional consent to have PK's collected
    id
    OG000
    title
    Study Subjects Consented to PK Collection
param Type
MEAN
population Description
12 subjects from both Stratum 1 and 2 were analyzed together as one group as per statistical analysis plan.
reporting Status
POSTED
time Frame
Samples drawn at 5 timepoints: (0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose) on two different days
title
Peak Plasma Concentration (Cmax)
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice