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NCT00007345 · OUTCOME

Median Number of Cycles of Depsipeptide Administered

Depsipeptide to Treat Patients With Cutaneous T-Cell Lymphoma and Peripheral T-Cell Lymphoma · Source last updated 2017-05-16

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

Measure
MEDIAN
Unit
Cycles per patient
Interval / dispersion
Full Range
Time frame
83 cycles (i.e., each cycle is 21 days)

What was measured

Participants were administered Depsipeptide and cycles (each cycle is 21 days) were monitored from the prescribed dose or higher to determine reductions (if needed) to maintain tolerability.

Groups in this outcome

Peripheral T-cell Lymphoma (PTCL)

Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.

Cutaneous T-cell Lymphoma (CTCL)

Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.

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

Analysis denominator · Participants

GroupSource count
Peripheral T-cell Lymphoma (PTCL)47
Cutaneous T-cell Lymphoma (CTCL)84

Reported measurements

Source class 1
Values in Cycles per patient · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Peripheral T-cell Lymphoma (PTCL)3Not reported183Not reported
Cutaneous T-cell Lymphoma (CTCL)4.5Not reported179Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        83
        value
        3
      2. group Id
        OG001
        lower Limit
        1
        upper Limit
        79
        value
        4.5
denoms
  1. counts
    1. group Id
      OG000
      value
      47
    2. group Id
      OG001
      value
      84
    units
    Participants
description
Participants were administered Depsipeptide and cycles (each cycle is 21 days) were monitored from the prescribed dose or higher to determine reductions (if needed) to maintain tolerability.
dispersion Type
Full Range
groups
  1. description
    Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
    id
    OG000
    title
    Peripheral T-cell Lymphoma (PTCL)
  2. description
    Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m\^2 and at 17.5 mg/m\^2 on days 1, 8, and 15 of a 28 day cycle.
    id
    OG001
    title
    Cutaneous T-cell Lymphoma (CTCL)
param Type
MEDIAN
reporting Status
POSTED
time Frame
83 cycles (i.e., each cycle is 21 days)
title
Median Number of Cycles of Depsipeptide Administered
type
SECONDARY
unit Of Measure
Cycles per patient

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

Preserved source evidence · Not medical advice