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NCT02159365 · OUTCOME

Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period

Study of Safety of Elotuzumab Administered Over Approximately 60 Minutes in Combination With Lenalidomide and Dexamethasone for Newly Diagnosed or Relapsed/Refractory Multiple Myeloma Patients · Source last updated 2019-07-16

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Date of first dose up to 60 days post last dose (approximately 4 years)

What was measured

An infusion reaction in this study is defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.

Analysis population: All treated participants

Groups in this outcome

E-Ld

E-Ld refers to the combination of Elotuzumab with Lenalidomide/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
E-Ld70

Reported measurements

# of participants with any grade infusion reaction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
E-Ld3Not reportedNot reportedNot reportedNot reported
# of participants with G3/4 infusion reaction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
E-Ld1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    # of participants with any grade infusion reaction
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    # of participants with G3/4 infusion reaction
denoms
  1. counts
    1. group Id
      OG000
      value
      70
    units
    Participants
description
An infusion reaction in this study is defined as any relevant sign or symptom occurring during or after elotuzumab infusion and considered by the investigator as an infusion reaction. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Potentially Life-threatening or disabling, Gr 5=Death.
groups
  1. description
    E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.
    id
    OG000
    title
    E-Ld
param Type
COUNT_OF_PARTICIPANTS
population Description
All treated participants
reporting Status
POSTED
time Frame
Date of first dose up to 60 days post last dose (approximately 4 years)
title
Number of Participants With Any Grade and Grade 3 or Grade 4 (G3/4) Infusion Reactions Over the Entire Study Period
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice