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NCT01088984 · OUTCOME

Area Under the Plasma Drug Concentration by Time Curve From Time 0 Until the Last Measurable Plasma Concentration (AUC0-t) for Bendamustine and Its Metabolites (M3 and M4)

Study of Bendamustine Hydrochloride for the Treatment of Pediatric Patients With Relapsed or Refractory Acute Leukemia · Source last updated 2016-05-23

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

Measure
GEOMETRIC_MEAN
Unit
ng*hr/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.

Analysis population: The pharmacokinetic analysis set included all participants who were in the safety analysis set (ie, those treated at any dose of bendamustine) who had valid pharmacokinetic data; n=number of participants with valid data for this assessment.

Groups in this outcome

Bendamustine 90 mg/m^2

Bendamustine 90 mg/m\^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.

Bendamustine 120 mg/m^2

Bendamustine 120 mg/m\^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.

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

Analysis denominator · Participants

GroupSource count
Bendamustine 90 mg/m^25
Bendamustine 120 mg/m^237

Reported measurements

Bendamustine; n=5, 37
Values in ng*hr/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Bendamustine 90 mg/m^211174.8651.73Not reportedNot reportedNot reported
Bendamustine 120 mg/m^211046.3258.58Not reportedNot reportedNot reported
Metabolite M3; n=5, 36
Values in ng*hr/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Bendamustine 90 mg/m^2697.0988.37Not reportedNot reportedNot reported
Bendamustine 120 mg/m^2701.1967.38Not reportedNot reportedNot reported
Metabolite M4; n=5, 37
Values in ng*hr/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Bendamustine 90 mg/m^243.80109.72Not reportedNot reportedNot reported
Bendamustine 120 mg/m^272.7857.11Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        51.73
        value
        11174.86
      2. group Id
        OG001
        spread
        58.58
        value
        11046.32
    title
    Bendamustine; n=5, 37
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        88.37
        value
        697.09
      2. group Id
        OG001
        spread
        67.38
        value
        701.19
    title
    Metabolite M3; n=5, 36
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        109.72
        value
        43.80
      2. group Id
        OG001
        spread
        57.11
        value
        72.78
    title
    Metabolite M4; n=5, 37
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      37
    units
    Participants
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Bendamustine 90 mg/m\^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
    id
    OG000
    title
    Bendamustine 90 mg/m^2
  2. description
    Bendamustine 120 mg/m\^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
    id
    OG001
    title
    Bendamustine 120 mg/m^2
param Type
GEOMETRIC_MEAN
population Description
The pharmacokinetic analysis set included all participants who were in the safety analysis set (ie, those treated at any dose of bendamustine) who had valid pharmacokinetic data; n=number of participants with valid data for this assessment.
reporting Status
POSTED
time Frame
Cycle 1, Day 1: before infusion, immediately following the infusion, and 3, 6, 10(±2), and 24 hours after the start of infusion. The 24-hour postinfusion sample was obtained before the start of the infusion on Day 2.
title
Area Under the Plasma Drug Concentration by Time Curve From Time 0 Until the Last Measurable Plasma Concentration (AUC0-t) for Bendamustine and Its Metabolites (M3 and M4)
type
SECONDARY
unit Of Measure
ng*hr/mL

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

Preserved source evidence · Not medical advice