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NCT00425555 · OUTCOME

Time of Clast (Tlast) of Panobinostat

Study of Oral LBH589 in Adult Patients With Refractory Cutaneous T-Cell Lymphoma · Source last updated 2021-08-20

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

All Participants

Participants received Panobinostat 20 mg/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
All Participants139

Reported measurements

Day 1

Analysis denominator · Participants

GroupSource count
All Participants109
Values in Hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
All Participants47.9Not reported23.4049.50Not reported
Day 8

Analysis denominator · Participants

GroupSource count
All Participants60
Values in Hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
All ParticipantsNANot reported16.8047.00below the level of detection
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        23.40
        upper Limit
        49.50
        value
        47.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        109
      units
      Participants
    title
    Day 1
  2. categories
    1. measurements
      1. comment
        below the level of detection
        group Id
        OG000
        lower Limit
        16.80
        upper Limit
        47.00
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        60
      units
      Participants
    title
    Day 8
denoms
  1. counts
    1. group Id
      OG000
      value
      139
    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/day capsule orally, OD on 3 days per week. (Monday, Wednesday and Friday or alternative Day 1, 3 and 5). The treatment duration was not fixed. Participants continued treatment until disease progression or unacceptable toxicity occurred.
    id
    OG000
    title
    All Participants
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-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice