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NCT02232516 · OUTCOME

Incidence of Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma · Source last updated 2026-06-12

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Evaluated once per cycle (1 cycle=28 days) up to 1 year.

What was measured

The frequency and severity of toxicity events will be evaluated. All adverse events will be summarized as to type, severity, frequency, timing and attribution. Grade 3 or greater AEs that occurred in at least 10% of the patients are reported here

Groups in this outcome

Treatment (Romidepsin, Lenalidomide)

Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV lenalidomide: Given PO laboratory biomarker analysis: Correlative studies

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

Analysis denominator · Participants

GroupSource count
Treatment (Romidepsin, Lenalidomide)29

Reported measurements

Thrombocytopenia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Romidepsin, Lenalidomide)10Not reportedNot reportedNot reportedNot reported
Anemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Romidepsin, Lenalidomide)8Not reportedNot reportedNot reportedNot reported
Lung Infection
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Romidepsin, Lenalidomide)3Not reportedNot reportedNot reportedNot reported
Sepsis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Romidepsin, Lenalidomide)3Not reportedNot reportedNot reportedNot reported
Hypoalbuminemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Romidepsin, Lenalidomide)7Not reportedNot reportedNot reportedNot reported
Fatigue
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Romidepsin, Lenalidomide)5Not reportedNot reportedNot reportedNot reported
Hyponatremia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Romidepsin, Lenalidomide)13Not reportedNot reportedNot reportedNot reported
Hypertension
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Romidepsin, Lenalidomide)11Not reportedNot reportedNot reportedNot reported
Hypokalemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Romidepsin, Lenalidomide)4Not reportedNot reportedNot reportedNot reported
Hyperglycemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Romidepsin, Lenalidomide)4Not reportedNot reportedNot reportedNot reported
Blood Bilirubin Increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Romidepsin, Lenalidomide)4Not reportedNot reportedNot reportedNot reported
Dehydration
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Romidepsin, Lenalidomide)3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    Thrombocytopenia
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Anemia
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Lung Infection
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Sepsis
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    Hypoalbuminemia
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Fatigue
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    Hyponatremia
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    Hypertension
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Hypokalemia
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Hyperglycemia
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Blood Bilirubin Increased
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Dehydration
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    units
    Participants
description
The frequency and severity of toxicity events will be evaluated. All adverse events will be summarized as to type, severity, frequency, timing and attribution. Grade 3 or greater AEs that occurred in at least 10% of the patients are reported here
groups
  1. description
    Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity. romidepsin: Given IV lenalidomide: Given PO laboratory biomarker analysis: Correlative studies
    id
    OG000
    title
    Treatment (Romidepsin, Lenalidomide)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Evaluated once per cycle (1 cycle=28 days) up to 1 year.
title
Incidence of Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice