Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00445068 · OUTCOME

Time to Peak Concentration (Tmax) 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
MEDIAN
Unit
Hours
Interval / dispersion
Full Range
Time frame
Pre-dose, 0.25, 1-2, and 3-4 hours post dose on Day 1 and Day 8

What was measured

Tmax is defined as the time at which the Cmax occurs. It will be obtained from the Tmax parameter calculated by WinNonlin®. If there is no measurable Cmax in the subject's pharmacokinetic (PK) profile, then Tmax will be missing for that subject. Tmax will be reported in units of h.

Analysis population: The analysis was performed in Pharmacokinetic Analysis (PAS) population, defined as all participants who provide at least one post-dose Pharmacokinetic (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

GroupSource count
Panobinostat27

Reported measurements

Day 1
Values in Hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Panobinostat1.7Not reported0.25.2Not reported
Day 8
Values in Hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Panobinostat1.2Not reported0.223.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.2
        upper Limit
        5.2
        value
        1.7
    title
    Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.2
        upper Limit
        23.7
        value
        1.2
    title
    Day 8
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    units
    Participants
description
Tmax is defined as the time at which the Cmax occurs. It will be obtained from the Tmax parameter calculated by WinNonlin®. If there is no measurable Cmax in the subject's pharmacokinetic (PK) profile, then Tmax will be missing for that subject. Tmax will be reported in units of h.
dispersion Type
Full Range
groups
  1. 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
MEDIAN
population Description
The analysis was performed in Pharmacokinetic Analysis (PAS) population, defined as all participants who provide at least one post-dose Pharmacokinetic (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
Time to Peak Concentration (Tmax) of Panobinostat
type
SECONDARY
unit Of Measure
Hours

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

Preserved source evidence · Not medical advice