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NCT01698801 · OUTCOME

Number of Participants With Adverse Events

A Phase 2 Study of Lenalidomide to Evaluate the Efficacy in Japanese Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2018-11-08

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 first dose of study drug treatment through to 28 days after the last dose, until the data cut-off date of 15 July 2014; median treatment duration was 60 weeks

What was measured

An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.

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

Groups in this outcome

Lenalidomide Plus Dexamethasone

Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason. Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.

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 Plus Dexamethasone26

Reported measurements

Any adverse event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone26Not reportedNot reportedNot reportedNot reported
TEAE related to study drug
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone25Not reportedNot reportedNot reportedNot reported
TEAE related to Lenalidomide
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone25Not reportedNot reportedNot reportedNot reported
TEAE related to Dexamethasone
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone20Not reportedNot reportedNot reportedNot reported
Grade 3-4 adverse event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone18Not reportedNot reportedNot reportedNot reported
Grade 3-4 adverse event related to any study drug
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone15Not reportedNot reportedNot reportedNot reported
Grade 3-4 adverse event related to Lenalidomide
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone15Not reportedNot reportedNot reportedNot reported
Grade 3-4 adverse event related to Dexamethasone
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone4Not reportedNot reportedNot reportedNot reported
Serious TEAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone11Not reportedNot reportedNot reportedNot reported
Serious TEAE related to any study drug
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone8Not reportedNot reportedNot reportedNot reported
Serious TEAE related to Lenalidomide
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone8Not reportedNot reportedNot reportedNot reported
Serious TEAE related to Dexamethasone
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone3Not reportedNot reportedNot reportedNot reported
TEAE leading to discontinuation of either drug
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone4Not reportedNot reportedNot reportedNot reported
TEAE leading to discontinuation of lenalidomide
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone4Not reportedNot reportedNot reportedNot reported
TEAE leading to discontinuation of dexamethasone
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone2Not reportedNot reportedNot reportedNot reported
Related TEAE discontinuation of either drug
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone4Not reportedNot reportedNot reportedNot reported
Related TEAE discontinuation of lenalidomide
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone4Not reportedNot reportedNot reportedNot reported
Related TEAE discontinuation of dexamethasone
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        26
    title
    Any adverse event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        25
    title
    TEAE related to study drug
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        25
    title
    TEAE related to Lenalidomide
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        20
    title
    TEAE related to Dexamethasone
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        18
    title
    Grade 3-4 adverse event
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        15
    title
    Grade 3-4 adverse event related to any study drug
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        15
    title
    Grade 3-4 adverse event related to Lenalidomide
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Grade 3-4 adverse event related to Dexamethasone
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        11
    title
    Serious TEAE
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Serious TEAE related to any study drug
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Serious TEAE related to Lenalidomide
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Serious TEAE related to Dexamethasone
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    units
    Participants
description
An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.
groups
  1. description
    Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason. Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.
    id
    OG000
    title
    Lenalidomide Plus Dexamethasone
param Type
NUMBER
population Description
Safety population includes all participants who received at least one dose of study drug.
reporting Status
POSTED
time Frame
From first dose of study drug treatment through to 28 days after the last dose, until the data cut-off date of 15 July 2014; median treatment duration was 60 weeks
title
Number of Participants With Adverse Events
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice