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NCT00448357 · OUTCOME

Capacity of Test Dosing of Busulfan That Would Result in the Desired Area Under the Curve Concentration Exposure of Patients Receiving a Full-dose Busulfan Regimen

Allogeneic Hematopoietic Cell Transplantation for Patients With Busulfex-based Regimen · Source last updated 2017-07-17

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

Measure
NUMBER
Unit
percentage of error
Interval / dispersion
Not reported
Time frame
Day -15 to Day -11

What was measured

Test doses of busulfan were administered and plasma levels were measured to determine a targeted AUC dosing estimate. The capacity is reported as the precision with which these test dose goals predicted the actual 90-hour mean AUC levels.Dose targeting precision was estimated by root mean squared error.

Groups in this outcome

Dose Level 1

Target AUC/24 hrs of 4800 uM-min +/-15%

Dose Level 2

Target AUC/24 hrs of 5760 uM-min +/- 15%

Dose Level 3

Target AUC/24 hrs of 6912 uM-min +/- 15%

Dose Level 4

Target AUC/24 hrs of 7603 uM-min+/- 15%

Dose Level 5

Target AUC/24 hrs of 8363 uM-min+/- 15%

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

Analysis denominator · Participants

GroupSource count
Dose Level 114
Dose Level 27
Dose Level 324
Dose Level 47
Dose Level 52

Reported measurements

Source class 1
Values in percentage of error · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 111.7Not reportedNot reportedNot reportedNot reported
Dose Level 24.9Not reportedNot reportedNot reportedNot reported
Dose Level 310.2Not reportedNot reportedNot reportedNot reported
Dose Level 411.1Not reportedNot reportedNot reportedNot reported
Dose Level 515.9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11.7
      2. group Id
        OG001
        value
        4.9
      3. group Id
        OG002
        value
        10.2
      4. group Id
        OG003
        value
        11.1
      5. group Id
        OG004
        value
        15.9
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      24
    4. group Id
      OG003
      value
      7
    5. group Id
      OG004
      value
      2
    units
    Participants
description
Test doses of busulfan were administered and plasma levels were measured to determine a targeted AUC dosing estimate. The capacity is reported as the precision with which these test dose goals predicted the actual 90-hour mean AUC levels.Dose targeting precision was estimated by root mean squared error.
groups
  1. description
    Target AUC/24 hrs of 4800 uM-min +/-15%
    id
    OG000
    title
    Dose Level 1
  2. description
    Target AUC/24 hrs of 5760 uM-min +/- 15%
    id
    OG001
    title
    Dose Level 2
  3. description
    Target AUC/24 hrs of 6912 uM-min +/- 15%
    id
    OG002
    title
    Dose Level 3
  4. description
    Target AUC/24 hrs of 7603 uM-min+/- 15%
    id
    OG003
    title
    Dose Level 4
  5. description
    Target AUC/24 hrs of 8363 uM-min+/- 15%
    id
    OG004
    title
    Dose Level 5
param Type
NUMBER
reporting Status
POSTED
time Frame
Day -15 to Day -11
title
Capacity of Test Dosing of Busulfan That Would Result in the Desired Area Under the Curve Concentration Exposure of Patients Receiving a Full-dose Busulfan Regimen
type
SECONDARY
unit Of Measure
percentage of error

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

Preserved source evidence · Not medical advice