Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01335399 · OUTCOME

Mean Change From Baseline of Pain Severity Score and Pain Interference Score

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma · Source last updated 2022-09-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
Rating score
Interval / dispersion
Standard Deviation
Time frame
From Baseline to End of Treatment (approximately 8 years)

What was measured

Pain severity (sensory dimension) and pain interference (reactive dimension, assessing the degree to which pain interferes with function) are measured using the Brief Pain Inventory- Short Form (BPI-SF). BPI-SF numeric rating scale goes from 0 (No pain) to 10 (Pain as bad as you can imagine).

Analysis population: All randomized participants

Groups in this outcome

E-Ld Cohort

Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle

Ld Cohort

Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 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
E-Ld Cohort374
Ld Cohort374

Reported measurements

Pain Severity
Values in Rating score · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
E-Ld Cohort0.022.645Not reportedNot reportedNot reported
Ld Cohort-0.252.721Not reportedNot reportedNot reported
Pain Interference
Values in Rating score · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
E-Ld Cohort0.333.077Not reportedNot reportedNot reported
Ld Cohort-0.183.082Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        2.645
        value
        0.02
      2. group Id
        OG001
        spread
        2.721
        value
        -0.25
    title
    Pain Severity
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.077
        value
        0.33
      2. group Id
        OG001
        spread
        3.082
        value
        -0.18
    title
    Pain Interference
denoms
  1. counts
    1. group Id
      OG000
      value
      374
    2. group Id
      OG001
      value
      374
    units
    Participants
description
Pain severity (sensory dimension) and pain interference (reactive dimension, assessing the degree to which pain interferes with function) are measured using the Brief Pain Inventory- Short Form (BPI-SF). BPI-SF numeric rating scale goes from 0 (No pain) to 10 (Pain as bad as you can imagine).
dispersion Type
Standard Deviation
groups
  1. description
    Participants receiving a combination of Elotuzumab (E) Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
    id
    OG000
    title
    E-Ld Cohort
  2. description
    Participants receiving a combination of Lenalidomide (L) Dexamethasone (d) in a 28 day cycle
    id
    OG001
    title
    Ld Cohort
param Type
MEAN
population Description
All randomized participants
reporting Status
POSTED
time Frame
From Baseline to End of Treatment (approximately 8 years)
title
Mean Change From Baseline of Pain Severity Score and Pain Interference Score
type
SECONDARY
unit Of Measure
Rating score

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

Preserved source evidence · Not medical advice