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NCT00420849 · OUTCOME

Time to First Peripheral Neuropathy Treatment-Emergent Adverse Event (TEAE)

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
MEAN
Unit
weeks
Interval / dispersion
Standard Deviation
Time frame
up to 124 weeks

What was measured

Time between first dose and when a TEAE for peripheral neuropathy was reported. The mean is the univariate mean without adjusting for censoring. The treatment duration was used for censored participants.

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

Source class 1
Values in weeks · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Lenalidomide Plus Dexamethasone25.621.53Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.53
        value
        25.6
denoms
  1. counts
    1. group Id
      OG000
      value
      587
    units
    Participants
description
Time between first dose and when a TEAE for peripheral neuropathy was reported. The mean is the univariate mean without adjusting for censoring. The treatment duration was used for censored participants.
dispersion Type
Standard Deviation
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
MEAN
population Description
Safety population
reporting Status
POSTED
time Frame
up to 124 weeks
title
Time to First Peripheral Neuropathy Treatment-Emergent Adverse Event (TEAE)
type
SECONDARY
unit Of Measure
weeks

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

Preserved source evidence · Not medical advice