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NCT00445068 · OUTCOME

Time of Clast (Tlast) 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

Time of Clast (Tlast) will be obtained from the Tlast parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Tlast will be missing for that participants. Tlast will be reported in units of h.

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

GroupSource count
Panobinostat27

Reported measurements

Day 1
Values in Hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Panobinostat47.8Not reported2450.2Not reported
Day 8
Values in Hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Panobinostat24.3Not reported3.328.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        24
        upper Limit
        50.2
        value
        47.8
    title
    Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.3
        upper Limit
        28.0
        value
        24.3
    title
    Day 8
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    units
    Participants
description
Time of Clast (Tlast) will be obtained from the Tlast parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Tlast will be missing for that participants. Tlast 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 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
Time of Clast (Tlast) of Panobinostat
type
SECONDARY
unit Of Measure
Hours

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

Preserved source evidence · Not medical advice