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NCT00274651 · OUTCOME

Objective Response Rate in Patients With Recurrent or Refractory Peripheral T-cell Lymphoma (PTCL))

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
NUMBER
Unit
percentage of patients with OR
Interval / dispersion
Not reported
Time frame
throughout the study, or for a maximum of 2 years

What was measured

Tumor response was assessed using the revised criteria of Cheson (Cheson 2007).Tumor assessments were done using conventional radiographic methods, e.g. CT or CT/PET.

Analysis population: Primary efficacy analysis is based on the ITT analysis set, where the OR are calculated, and the proportion ± 80% CI (confidence interval) specified by Koyama \& Chen (2008) are presented

Groups in this outcome

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
PTCL (ITT Population)24

Reported measurements

Source class 1
Values in percentage of patients with OR · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
PTCL (ITT Population)25Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        25
denoms
  1. counts
    1. group Id
      OG000
      value
      24
    units
    Participants
description
Tumor response was assessed using the revised criteria of Cheson (Cheson 2007).Tumor assessments were done using conventional radiographic methods, e.g. CT or CT/PET.
groups
  1. description
    PTCL patients will receive 1000 mg/m2 of PXD101 IV belinostat: 1000 mg/m2 for 5 days every 21 days; IV
    id
    OG000
    title
    PTCL (ITT Population)
param Type
NUMBER
population Description
Primary efficacy analysis is based on the ITT analysis set, where the OR are calculated, and the proportion ± 80% CI (confidence interval) specified by Koyama \& Chen (2008) are presented
reporting Status
POSTED
time Frame
throughout the study, or for a maximum of 2 years
title
Objective Response Rate in Patients With Recurrent or Refractory Peripheral T-cell Lymphoma (PTCL))
type
PRIMARY
unit Of Measure
percentage of patients with OR

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

Preserved source evidence · Not medical advice