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NCT01088984 · OUTCOME

Maximum Observed Plasma Drug Concentration (Cmax) 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/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/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Bendamustine 90 mg/m^25093.2460.39Not reportedNot reportedNot reported
Bendamustine 120 mg/m^26401.8052.90Not reportedNot reportedNot reported
Metabolite M3; n=5, 36
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Bendamustine 90 mg/m^2311.7092.98Not reportedNot reportedNot reported
Bendamustine 120 mg/m^2403.5269.91Not reportedNot reportedNot reported
Metabolite M4; n=5, 37
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Bendamustine 90 mg/m^237.5382.97Not reportedNot reportedNot reported
Bendamustine 120 mg/m^248.2753.94Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        60.39
        value
        5093.24
      2. group Id
        OG001
        spread
        52.90
        value
        6401.80
    title
    Bendamustine; n=5, 37
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        92.98
        value
        311.70
      2. group Id
        OG001
        spread
        69.91
        value
        403.52
    title
    Metabolite M3; n=5, 36
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        82.97
        value
        37.53
      2. group Id
        OG001
        spread
        53.94
        value
        48.27
    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
Maximum Observed Plasma Drug Concentration (Cmax) for Bendamustine and Its Metabolites (M3 and M4)
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice