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NCT00106431 · OUTCOME

Percent of Pts With Objective Disease Control

A Single Agent Phase II Study of Romidepsin (Depsipeptide, FK228) in the Treatment of Cutaneous T-cell Lymphoma (CTCL) · Source last updated 2019-10-30

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

Measure
NUMBER
Unit
Percent of participants
Interval / dispersion
Not reported
Time frame
Up to 10 months

What was measured

The percent of pts with confirmed ODC (CR, CCR, PR and SD90) based on OPDREC was summarized.

Analysis population: Efficacy analysis based on interim analysis of data for as treated population

Groups in this outcome

Romidepsin

Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.

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

Analysis denominator · Participants

GroupSource count
Romidepsin96

Reported measurements

Source class 1
Values in Percent of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romidepsin64Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        64
denoms
  1. counts
    1. group Id
      OG000
      value
      96
    units
    Participants
description
The percent of pts with confirmed ODC (CR, CCR, PR and SD90) based on OPDREC was summarized.
groups
  1. description
    Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
    id
    OG000
    title
    Romidepsin
param Type
NUMBER
population Description
Efficacy analysis based on interim analysis of data for as treated population
reporting Status
POSTED
time Frame
Up to 10 months
title
Percent of Pts With Objective Disease Control
type
SECONDARY
unit Of Measure
Percent of participants

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

Preserved source evidence · Not medical advice