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NCT00425555 · OUTCOME

Progression-free Survival (PFS)

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
months
Interval / dispersion
95% Confidence Interval
Time frame
Baseline up to Cycle 12, an average of 12 months

What was measured

PFS is defined as time from first dose of study treatment to progression or death due to any cause, based on modified European Society for Bone and Marrow Transplantation (EBMT) criteria per Investigator's assessment

Analysis population: The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.

Groups in this outcome

Bexarotene Exposed

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.

Bexarotene Naive

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.

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
Bexarotene Exposed79
Bexarotene Naive60
All Participants139

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bexarotene Exposed127.0Not reported87.0197.0Not reported
Bexarotene Naive113.0Not reported85.0142.0Not reported
All Participants114.0Not reported87.0143.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        87.0
        upper Limit
        197.0
        value
        127.0
      2. group Id
        OG001
        lower Limit
        85.0
        upper Limit
        142.0
        value
        113.0
      3. group Id
        OG002
        lower Limit
        87.0
        upper Limit
        143.0
        value
        114.0
denoms
  1. counts
    1. group Id
      OG000
      value
      79
    2. group Id
      OG001
      value
      60
    3. group Id
      OG002
      value
      139
    units
    Participants
description
PFS is defined as time from first dose of study treatment to progression or death due to any cause, based on modified European Society for Bone and Marrow Transplantation (EBMT) criteria per Investigator's assessment
dispersion Type
95% Confidence Interval
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
    Bexarotene Exposed
  2. 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
    OG001
    title
    Bexarotene Naive
  3. 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
    OG002
    title
    All Participants
param Type
MEDIAN
population Description
The analysis was performed in FAS population was defined according to the intention-to-treat principle. This population will include all participants enrolled into the study.
reporting Status
POSTED
time Frame
Baseline up to Cycle 12, an average of 12 months
title
Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice