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NCT00928486 · OUTCOME

Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)

A Safety Confirmation Study on Lenalidomide With Dexamethasone In Japanese Patients With Previously Treated Multiple Myeloma · Source last updated 2019-11-20

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
Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks

What was measured

A TEAE was defined as any AE that started on or after the first dose of study drug, and within End of Study (EOS) (28 days after the last dose of study drug received). A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; or constitutes an important medical event. The intensity of AEs were graded 1 to 5 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. For all other AEs not described in the CTCAE criteria, the intensity was assessed by the investigator as mild grade (Grade 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4) or death (grade 5)

Analysis population: Safety population included all 25 participants who received at least one dose of study drug.

Groups in this outcome

Lenalidomide and Dexamethasone

Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance \<60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.

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

Analysis denominator · Participants

GroupSource count
Lenalidomide and Dexamethasone25

Reported measurements

Any Adverse Event (AE)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Dexamethasone25Not reportedNot reportedNot reportedNot reported
Drug-Related AE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Dexamethasone25Not reportedNot reportedNot reportedNot reported
Grade 3-4 Adverse Event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Dexamethasone22Not reportedNot reportedNot reportedNot reported
Drug-Related Grade 3-4 AE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Dexamethasone21Not reportedNot reportedNot reportedNot reported
Serious Adverse Event (SAE)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Dexamethasone12Not reportedNot reportedNot reportedNot reported
Drug-Related SAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Dexamethasone9Not reportedNot reportedNot reportedNot reported
AE Leading to Study Drug Discontinuation
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Dexamethasone4Not reportedNot reportedNot reportedNot reported
Related AE Leading to Len/Dex Discontinuation
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Dexamethasone2Not reportedNot reportedNot reportedNot reported
AE leading to dose reduction or interruption
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Dexamethasone17Not reportedNot reportedNot reportedNot reported
Related AE leading to dose reduction/interruption
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide and Dexamethasone16Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        25
    title
    Any Adverse Event (AE)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        25
    title
    Drug-Related AE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        22
    title
    Grade 3-4 Adverse Event
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        21
    title
    Drug-Related Grade 3-4 AE
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        12
    title
    Serious Adverse Event (SAE)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Drug-Related SAE
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    AE Leading to Study Drug Discontinuation
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Related AE Leading to Len/Dex Discontinuation
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        17
    title
    AE leading to dose reduction or interruption
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        16
    title
    Related AE leading to dose reduction/interruption
denoms
  1. counts
    1. group Id
      OG000
      value
      25
    units
    Participants
description
A TEAE was defined as any AE that started on or after the first dose of study drug, and within End of Study (EOS) (28 days after the last dose of study drug received). A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; or constitutes an important medical event. The intensity of AEs were graded 1 to 5 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. For all other AEs not described in the CTCAE criteria, the intensity was assessed by the investigator as mild grade (Grade 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4) or death (grade 5)
groups
  1. description
    Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance \<60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
    id
    OG000
    title
    Lenalidomide and Dexamethasone
param Type
NUMBER
population Description
Safety population included all 25 participants who received at least one dose of study drug.
reporting Status
POSTED
time Frame
Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
title
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice