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NCT00056160 · OUTCOME

Time to First Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (Best Score=0, Fully Active, Able to Carry on All Pre-disease Performance Without Restriction; Worst Score=5, Dead.)

CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma · Source last updated 2017-10-19

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
30 weeks (mean time to first worsening of ECOG performance status for CC-5013/Dex treatment group)

What was measured

The time to first worsening on the ECOG Performance Scale was calculated as the time from randomization to the date of the first worsening compared to the last ECOG evaluation obtained prior to randomization.

Analysis population: Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.

Groups in this outcome

CC-5013/Dex

CC-5013 (lenalidomide) plus oral high-dose dexamethasone

Placebo/Dex

Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone

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

Analysis denominator · Participants

GroupSource count
CC-5013/Dex177
Placebo/Dex176

Reported measurements

Source class 1
Values in Weeks · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
CC-5013/Dex29.930.02Not reportedNot reportedNot reported
Placebo/Dex15.016.98Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        30.02
        value
        29.9
      2. group Id
        OG001
        spread
        16.98
        value
        15.0
denoms
  1. counts
    1. group Id
      OG000
      value
      177
    2. group Id
      OG001
      value
      176
    units
    Participants
description
The time to first worsening on the ECOG Performance Scale was calculated as the time from randomization to the date of the first worsening compared to the last ECOG evaluation obtained prior to randomization.
dispersion Type
Standard Deviation
groups
  1. description
    CC-5013 (lenalidomide) plus oral high-dose dexamethasone
    id
    OG000
    title
    CC-5013/Dex
  2. description
    Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
    id
    OG001
    title
    Placebo/Dex
param Type
MEAN
population Description
Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.
reporting Status
POSTED
time Frame
30 weeks (mean time to first worsening of ECOG performance status for CC-5013/Dex treatment group)
title
Time to First Worsening of Eastern Cooperative Oncology Group (ECOG) Performance Status Scale (Best Score=0, Fully Active, Able to Carry on All Pre-disease Performance Without Restriction; Worst Score=5, Dead.)
type
SECONDARY
unit Of Measure
Weeks

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

Preserved source evidence · Not medical advice