NCT01088984 · OUTCOME

Area Under the Plasma Drug Concentration by Time Curve From Time 0 Until 24 Hours After Study Drug Administration (AUC0-24) 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

Group	Source count
Bendamustine 90 mg/m^2	5
Bendamustine 120 mg/m^2	37

Reported measurements

Bendamustine; n=1, 13

Values in ng*hr/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine 90 mg/m^2	14998.00	NA	Not reported	Not reported	only 1 participant assessed
Bendamustine 120 mg/m^2	12929.22	50.46	Not reported	Not reported	Not reported

Metabolite M3; n=0, 2

Values in ng*hr/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine 90 mg/m^2	NA	NA	Not reported	Not reported	no participants assessed
Bendamustine 120 mg/m^2	1336.89	1.80	Not reported	Not reported	Not reported

Metabolite M4; n=0, 0

Values in ng*hr/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Bendamustine 90 mg/m^2	NA	NA	Not reported	Not reported	no participants assessed
Bendamustine 120 mg/m^2	NA	NA	Not reported	Not reported	no participants assessed

Complete source fields

classes

categories
measurements
comment
only 1 participant assessed
group Id
OG000
spread
NA
value
14998.00
group Id
OG001
spread
50.46
value
12929.22
title
Bendamustine; n=1, 13
categories
measurements
comment
no participants assessed
group Id
OG000
spread
NA
value
NA
group Id
OG001
spread
1.80
value
1336.89
title
Metabolite M3; n=0, 2
categories
measurements
comment
no participants assessed
group Id
OG000
spread
NA
value
NA
comment
no participants assessed
group Id
OG001
spread
NA
value
NA
title
Metabolite M4; n=0, 0

denoms

counts
group Id
OG000
value
5
group Id
OG001
value
37
units
Participants

dispersion Type

Geometric Coefficient of Variation

groups

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
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 24 Hours After Study Drug Administration (AUC0-24) for Bendamustine and Its Metabolites (M3 and M4)

type

SECONDARY

unit Of Measure

ng*hr/mL

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Preserved source evidence · Not medical advice