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NCT00420849 · OUTCOME

Participants With Adverse Events of Special Interest: Peripheral Neuropathy

A Multicentre, Single-arm, Open-label Safety Study of Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma · Source last updated 2012-05-21

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 124 weeks

What was measured

Number of participants with at least one peripheral neuropathy treatment-emergent adverse event (TEAE), and number of participants reporting AEs coded to preferred terms that comprise the search terms for peripheral neuropathy in MedDRA version 9.0 are listed. A participant with multiple occurrences of a TEAE was counted only once for that category.

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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 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 Dexamethasone587

Reported measurements

At least one TEAE of peripheral neuropathy
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone84Not reportedNot reportedNot reportedNot reported
Neuropathy peripheral
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone46Not reportedNot reportedNot reportedNot reported
Peripheral sensory neuropathy
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone33Not reportedNot reportedNot reportedNot reported
Neuralgia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone5Not reportedNot reportedNot reportedNot reported
Peripheral motor neuropathy
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone2Not reportedNot reportedNot reportedNot reported
Polyneuropathy
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone2Not reportedNot reportedNot reportedNot reported
Sensory disturbance
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        84
    title
    At least one TEAE of peripheral neuropathy
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        46
    title
    Neuropathy peripheral
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        33
    title
    Peripheral sensory neuropathy
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Neuralgia
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Peripheral motor neuropathy
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Polyneuropathy
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Sensory disturbance
denoms
  1. counts
    1. group Id
      OG000
      value
      587
    units
    Participants
description
Number of participants with at least one peripheral neuropathy treatment-emergent adverse event (TEAE), and number of participants reporting AEs coded to preferred terms that comprise the search terms for peripheral neuropathy in MedDRA version 9.0 are listed. A participant with multiple occurrences of a TEAE was counted only once for that category.
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 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 124 weeks
title
Participants With Adverse Events of Special Interest: Peripheral Neuropathy
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice