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NCT00865969 · OUTCOME

Duration of Response

Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma · Source last updated 2021-10-29

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
24 months

What was measured

The Duration of Response was assessed by IWG criteria per the IRC from the date the measurement criteria were first met for CR or PR (whichever status was recorded first) until the first subsequent date that relapse or progression was documented. It was estimated by the Kaplan-Meier method. Response is defined as complete response (CR) or partial response (PR). CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites.

Analysis population: Efficacy Analysis Dataset included participants who received at least 1 dose of belinostat and had a confirmed PTCL diagnosis. Overall number of participants analysed included responding participants (CR/PR) only.

Groups in this outcome

Belinostat

Belinostat 1000 mg/m\^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.

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

Analysis denominator · Participants

GroupSource count
Belinostat31

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Belinostat13.6Not reported4.529.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.5
        upper Limit
        29.4
        value
        13.6
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    units
    Participants
description
The Duration of Response was assessed by IWG criteria per the IRC from the date the measurement criteria were first met for CR or PR (whichever status was recorded first) until the first subsequent date that relapse or progression was documented. It was estimated by the Kaplan-Meier method. Response is defined as complete response (CR) or partial response (PR). CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites.
dispersion Type
95% Confidence Interval
groups
  1. description
    Belinostat 1000 mg/m\^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities.
    id
    OG000
    title
    Belinostat
param Type
MEDIAN
population Description
Efficacy Analysis Dataset included participants who received at least 1 dose of belinostat and had a confirmed PTCL diagnosis. Overall number of participants analysed included responding participants (CR/PR) only.
reporting Status
POSTED
time Frame
24 months
title
Duration of Response
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice