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NCT01261247 · OUTCOME

Median Progression-free Survival Time

Panobinostat in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma · Source last updated 2022-05-24

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
Every 6 months for up to 2 years

What was measured

The median progression-free survival time is defined as the time from registration to progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. Progression is defined using the Cheson et al. Revised Response Criteria for Malignant Lymphoma as: Any new lesion or increase by ≥50% of previously involved sites from nadir, Appearance of a new lesion(s) \> 1.5 cm in any axis, ≥50% increase from nadir in SPD of more than one node, or ≥50% increase in longest diameter of a previously identified node \> 1 cm in short axis, Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy, \> 50% increase from nadir in the SPD of any previous lesions, New or recurrent involvement.

Groups in this outcome

Arm I (LBH589)

Patients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of 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
Arm I (LBH589)39

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm I (LBH589)3.1Not reported2.08.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.0
        upper Limit
        8.4
        value
        3.1
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    units
    Participants
description
The median progression-free survival time is defined as the time from registration to progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. Progression is defined using the Cheson et al. Revised Response Criteria for Malignant Lymphoma as: Any new lesion or increase by ≥50% of previously involved sites from nadir, Appearance of a new lesion(s) \> 1.5 cm in any axis, ≥50% increase from nadir in SPD of more than one node, or ≥50% increase in longest diameter of a previously identified node \> 1 cm in short axis, Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy, \> 50% increase from nadir in the SPD of any previous lesions, New or recurrent involvement.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive oral 40 mg panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Arm I (LBH589)
param Type
MEDIAN
reporting Status
POSTED
time Frame
Every 6 months for up to 2 years
title
Median Progression-free Survival Time
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice