NCT00445068 · OUTCOME

Area Under the Plasma Concentration (AUC0-24) of Panobinostat

Efficacy and Safety of LBH589B in Adult Patients With Multiple Myeloma · Source last updated 2021-07-14

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

Measure: MEAN
Unit: ng*hr/ml
Interval / dispersion: Standard Deviation
Time frame: Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8

What was measured

Area under the curve (AUC) is defined as the area under concentration-time curve as a measure of drug exposure. The area under the plasma concentration-time curve from time zero to 24 hours.

Analysis population: The analysis was performed in PAS population, defined as all participants who provide at least one post-dose PK plasma sample. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.

Groups in this outcome

Panobinostat

Participants received panobinostat 20 mg orally OD, three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle. Participants could continue treatment until disease progression or unacceptable toxicity.

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
Panobinostat	27

Reported measurements

Day 1

Values in ng*hr/ml · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Panobinostat	72.0	36.10	Not reported	Not reported	Not reported

Day 8

Values in ng*hr/ml · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Panobinostat	81.6	37.56	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
36.10
value
72.0
title
Day 1
categories
measurements
group Id
OG000
spread
37.56
value
81.6
title
Day 8

denoms

counts
group Id
OG000
value
27
units
Participants

description

Area under the curve (AUC) is defined as the area under concentration-time curve as a measure of drug exposure. The area under the plasma concentration-time curve from time zero to 24 hours.

dispersion Type

Standard Deviation

groups

description
Participants received panobinostat 20 mg orally OD, three times a week on days: 1, 3 and 5, then 8, 10 and 12, then 15, 17 and 19 of each cycle, as part of a 3-week (21 days) treatment cycle. Participants could continue treatment until disease progression or unacceptable toxicity.
id
OG000
title
Panobinostat

param Type

MEAN

population Description

The analysis was performed in PAS population, defined as all participants who provide at least one post-dose PK plasma sample. Here, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.

reporting Status

POSTED

time Frame

Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8

title

Area Under the Plasma Concentration (AUC0-24) of Panobinostat

type

SECONDARY

unit Of Measure

ng*hr/ml

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

Preserved source evidence · Not medical advice