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NCT00425555 · OUTCOME

Duration of Response (DOS)

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

What was measured

Duration of response and time to response were summarized. A Kaplan-Meier analysis of time to progression was performed, including estimation and 95% confidence interval of the median time to progression and progression-free survival.

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 Days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bexarotene Exposed170.0Not reported86.0294.0Not reported
Bexarotene NaiveNANot reported84.0NAThere were an insufficient number of participants with events and therefore the Median and Upper limit of the 95% CI for the duration of response could not be calculated.
All Participants280.0Not reported115.0311.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        86.0
        upper Limit
        294.0
        value
        170.0
      2. comment
        There were an insufficient number of participants with events and therefore the Median and Upper limit of the 95% CI for the duration of response could not be calculated.
        group Id
        OG001
        lower Limit
        84.0
        upper Limit
        NA
        value
        NA
      3. group Id
        OG002
        lower Limit
        115.0
        upper Limit
        311.0
        value
        280.0
denoms
  1. counts
    1. group Id
      OG000
      value
      79
    2. group Id
      OG001
      value
      60
    3. group Id
      OG002
      value
      139
    units
    Participants
description
Duration of response and time to response were summarized. A Kaplan-Meier analysis of time to progression was performed, including estimation and 95% confidence interval of the median time to progression and progression-free survival.
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
Duration of Response (DOS)
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice