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NCT01724177 · OUTCOME

Number of Participants With Treatment Emergent Adverse Events

A Phase 2 Study of Lenalidomide in Patients With Relapsed or Recurrent Adult T-cell Leukemia-lymphoma · Source last updated 2018-05-29

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
From the date of the first dose of study drug up to 28 days after the last dose of study drug; up to data cutoff date of 19 May 2017; maximum treatment duration was 130.1 weeks

What was measured

Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring on or after the start of study treatment and within 28 days after the last dose. Severity was assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0): Grade 1= Mild Grade 2= Moderate Grade 3= Severe Grade 4= Life-threatening and Grade 5= Death related to AE. Serious AEs (SAEs) were those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.

Analysis population: Safety population was defined as all participants who received at least one dose of lenalidomide. All safety analyses were based on the safety population.

Groups in this outcome

Lenalidomide

Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity

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

Analysis denominator · Participants

GroupSource count
Lenalidomide26

Reported measurements

≥ 1 TEAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide26Not reportedNot reportedNot reportedNot reported
≥ 1 TEAE Related to Lenalidomide
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide26Not reportedNot reportedNot reportedNot reported
≥ 1 NCI CTCAE Grade (GR) 3 or Greater TEAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide25Not reportedNot reportedNot reportedNot reported
≥ 1 NCI CTCAE ≥ GR 3 TEAE Related to Lenalidomide
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide25Not reportedNot reportedNot reportedNot reported
≥ 1 Serious TEAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide11Not reportedNot reportedNot reportedNot reported
≥ 1 Serious TEAE Related to Lenalidomide
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide9Not reportedNot reportedNot reportedNot reported
≥ 1 TEAE Leading to Discontinuation
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide8Not reportedNot reportedNot reportedNot reported
≥ 1 Related TEAE Leading to Discontinuation
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide8Not reportedNot reportedNot reportedNot reported
≥ 1 TEAE Leading to Dose Reduction/Interruption
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide17Not reportedNot reportedNot reportedNot reported
≥ 1 related TEAE Leading to Decrease/Interruption
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide17Not reportedNot reportedNot reportedNot reported
≥ 1 TEAE Resulting in Death
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        26
    title
    ≥ 1 TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        26
    title
    ≥ 1 TEAE Related to Lenalidomide
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        25
    title
    ≥ 1 NCI CTCAE Grade (GR) 3 or Greater TEAE
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        25
    title
    ≥ 1 NCI CTCAE ≥ GR 3 TEAE Related to Lenalidomide
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    ≥ 1 Serious TEAE
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    ≥ 1 Serious TEAE Related to Lenalidomide
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    ≥ 1 TEAE Leading to Discontinuation
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    ≥ 1 Related TEAE Leading to Discontinuation
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        17
    title
    ≥ 1 TEAE Leading to Dose Reduction/Interruption
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        17
    title
    ≥ 1 related TEAE Leading to Decrease/Interruption
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    ≥ 1 TEAE Resulting in Death
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    units
    Participants
description
Treatment Emergent Adverse Event (TEAE) was defined as any AE occurring on or after the start of study treatment and within 28 days after the last dose. Severity was assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0): Grade 1= Mild Grade 2= Moderate Grade 3= Severe Grade 4= Life-threatening and Grade 5= Death related to AE. Serious AEs (SAEs) were those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.
groups
  1. description
    Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
    id
    OG000
    title
    Lenalidomide
param Type
NUMBER
population Description
Safety population was defined as all participants who received at least one dose of lenalidomide. All safety analyses were based on the safety population.
reporting Status
POSTED
time Frame
From the date of the first dose of study drug up to 28 days after the last dose of study drug; up to data cutoff date of 19 May 2017; maximum treatment duration was 130.1 weeks
title
Number of Participants With Treatment Emergent Adverse Events
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Independent clinical review pending · Not medical advice