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NCT00478777 · OUTCOME

Participants With Treatment-emergent Adverse Experiences (TEAEs)

A Multicenter, Single-Arm, Open-Label Expanded Access Program for Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma · Source last updated 2011-11-03

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
up to 8 months

What was measured

Counts of study participants who had treatment-emergent adverse events (TEAEs) defined as any reported AE that started on or after the first day of study drug dosing. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) was used by investigators to assess TEAEs. Severity scale ranges from 0 (none) to 5 (death). Grade 3=severe AE; Grade 4=life threatening or disabling AE; Grade 5=death.

Analysis population: Safety population

Groups in this outcome

Lenalidomide Plus Dexamethasone

Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 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
Lenalidomide Plus Dexamethasone144

Reported measurements

>=1 TEAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone139Not reportedNot reportedNot reportedNot reported
>=1 TEAE related to study drug
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone119Not reportedNot reportedNot reportedNot reported
>=1 NCI CTCAE grade 3 or 4 TEAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone105Not reportedNot reportedNot reportedNot reported
>=1 NCI CTCAE grade 3 or 4 TEAE related to drug
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone83Not reportedNot reportedNot reportedNot reported
>=1 serious AE (SAE)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone79Not reportedNot reportedNot reportedNot reported
>=1 study drug related SAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone48Not reportedNot reportedNot reportedNot reported
Discontinued due to TEAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone32Not reportedNot reportedNot reportedNot reported
Discontinued due to TEAE related to study drug
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone21Not reportedNot reportedNot reportedNot reported
TEAE leading to dose reduction
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone35Not reportedNot reportedNot reportedNot reported
TEAE leading to dose interruption
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone64Not reportedNot reportedNot reportedNot reported
Deaths
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone79Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        139
    title
    >=1 TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        119
    title
    >=1 TEAE related to study drug
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        105
    title
    >=1 NCI CTCAE grade 3 or 4 TEAE
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        83
    title
    >=1 NCI CTCAE grade 3 or 4 TEAE related to drug
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        79
    title
    >=1 serious AE (SAE)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        48
    title
    >=1 study drug related SAE
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        32
    title
    Discontinued due to TEAE
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        21
    title
    Discontinued due to TEAE related to study drug
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        35
    title
    TEAE leading to dose reduction
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        64
    title
    TEAE leading to dose interruption
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        79
    title
    Deaths
denoms
  1. counts
    1. group Id
      OG000
      value
      144
    units
    Participants
description
Counts of study participants who had treatment-emergent adverse events (TEAEs) defined as any reported AE that started on or after the first day of study drug dosing. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) was used by investigators to assess TEAEs. Severity scale ranges from 0 (none) to 5 (death). Grade 3=severe AE; Grade 4=life threatening or disabling AE; Grade 5=death.
groups
  1. description
    Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
    id
    OG000
    title
    Lenalidomide Plus Dexamethasone
param Type
NUMBER
population Description
Safety population
reporting Status
POSTED
time Frame
up to 8 months
title
Participants With Treatment-emergent Adverse Experiences (TEAEs)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice