Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00007345 · OUTCOME

Number of Participants With Adverse Events

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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
147 months and 5 days

What was measured

Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.

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 participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Peripheral T-cell Lymphoma (PTCL)47Not reportedNot reportedNot reportedNot reported
Cutaneous T-cell Lymphoma (CTCL)84Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.01
    p Value Comment
    An exact Cochran-Armitage trend test was used to compare the distributions. In view of the large number of tests performed, we only refer to those with P-values \<0.01 as statistically significant, with those for which 0.01 \<P\< 0.05 considered trends.
    statistical Method
    Cochran-Armitage trend test
Complete source fields
analyses
  1. ci Num Sides
    TWO_SIDED
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.01
    p Value Comment
    An exact Cochran-Armitage trend test was used to compare the distributions. In view of the large number of tests performed, we only refer to those with P-values \<0.01 as statistically significant, with those for which 0.01 \<P\< 0.05 considered trends.
    statistical Method
    Cochran-Armitage trend test
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        47
      2. group Id
        OG001
        value
        84
denoms
  1. counts
    1. group Id
      OG000
      value
      47
    2. group Id
      OG001
      value
      84
    units
    Participants
description
Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
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
NUMBER
reporting Status
POSTED
time Frame
147 months and 5 days
title
Number of Participants With Adverse Events
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice