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NCT00106431 · OUTCOME

Decrease in Pruritus Visual Analogue Scale (VAS) Score of ≥30 mm or a Score of 0 for at Least 2 Consecutive Cycles.

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
participants
Interval / dispersion
Not reported
Time frame
Up to 10 months

What was measured

Pruritus was reported monthly by pts using a 0 (no itching) to 100 (unbearable itching) mm visual analog scale (VAS). Pts were considered to have significant pruritus if the baseline VAS score was ≥ 30 mm. Clinically meaningful reduction in pruritus was defined as a decrease in VAS score of ≥ 30 mm or a score of 0 for at least 2 consecutive cycles.

Analysis population: Patients meeting definition of moderate to severe pruritus on VAS (i.e., had a VAS of \>=30 mm)

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
Romidepsin52

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romidepsin25Not 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
      52
    units
    Participants
description
Pruritus was reported monthly by pts using a 0 (no itching) to 100 (unbearable itching) mm visual analog scale (VAS). Pts were considered to have significant pruritus if the baseline VAS score was ≥ 30 mm. Clinically meaningful reduction in pruritus was defined as a decrease in VAS score of ≥ 30 mm or a score of 0 for at least 2 consecutive cycles.
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
Patients meeting definition of moderate to severe pruritus on VAS (i.e., had a VAS of \>=30 mm)
reporting Status
POSTED
time Frame
Up to 10 months
title
Decrease in Pruritus Visual Analogue Scale (VAS) Score of ≥30 mm or a Score of 0 for at Least 2 Consecutive Cycles.
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice