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NCT00274651 · OUTCOME

Time to Progression

A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas · Source last updated 2015-07-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Days
Interval / dispersion
Full Range
Time frame
throughout the study, or for a maximum of 2 years

What was measured

Time to progression was defined as the interval between the first date of treatment and the first notation of disease progression.

Analysis population: Time to Progression (ITT population) was estimated using the Kaplan-Meier method for CTCL and PTCL arms. As progression was not observed in six patients in Arm A and 10 patients in Arm B, a total of 37 patients progressed, and the the median time to progression and the full range (days) are presented.

Groups in this outcome

Arm A (CTCL, ITT Population)

CTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV

Arm B (PTCL, ITT Population)

PTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV

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 A (CTCL, ITT Population)23
Arm B (PTCL, ITT Population)14

Reported measurements

Source class 1
Values in Days · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Arm A (CTCL, ITT Population)43Not reported15304Not reported
Arm B (PTCL, ITT Population)82Not reported9890Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15
        upper Limit
        304
        value
        43
      2. group Id
        OG001
        lower Limit
        9
        upper Limit
        890
        value
        82
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    2. group Id
      OG001
      value
      14
    units
    Participants
description
Time to progression was defined as the interval between the first date of treatment and the first notation of disease progression.
dispersion Type
Full Range
groups
  1. description
    CTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
    id
    OG000
    title
    Arm A (CTCL, ITT Population)
  2. description
    PTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
    id
    OG001
    title
    Arm B (PTCL, ITT Population)
param Type
MEDIAN
population Description
Time to Progression (ITT population) was estimated using the Kaplan-Meier method for CTCL and PTCL arms. As progression was not observed in six patients in Arm A and 10 patients in Arm B, a total of 37 patients progressed, and the the median time to progression and the full range (days) are presented.
reporting Status
POSTED
time Frame
throughout the study, or for a maximum of 2 years
title
Time to Progression
type
SECONDARY
unit Of Measure
Days

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

Preserved source evidence · Not medical advice