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NCT02395666 · OUTCOME

Area Under the Plasma Concentration Versus Time Curve (AUC)

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
hr*ng/mL
Interval / dispersion
90% Confidence Interval
Time frame
0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose on two different days

What was measured

Pharmacokinetic assay AUC(0-6 hr)/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 hr*ng/mL · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Study Subjects Consented to PK Collection47024Not reported2386870180Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        23868
        upper Limit
        70180
        value
        47024
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
Pharmacokinetic assay AUC(0-6 hr)/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
0 (pre dose), 30min, 1 hour, 3 hours, and 6 hours post-dose on two different days
title
Area Under the Plasma Concentration Versus Time Curve (AUC)
type
SECONDARY
unit Of Measure
hr*ng/mL

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

Preserved source evidence · Not medical advice