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NCT02159365 · OUTCOME

Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2

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
NUMBER
Unit
Participants
Interval / dispersion
95% Confidence Interval
Time frame
From Day 1 to End of cycle 2 treatment (approximately 56 days)

What was measured

Infusion reaction was 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

Source class 1
Values in Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
E-Ld0Not reported05.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        5.1
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      70
    units
    Participants
description
Infusion reaction was 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.
dispersion Type
95% Confidence Interval
groups
  1. description
    E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.
    id
    OG000
    title
    E-Ld
param Type
NUMBER
population Description
All Treated Participants
reporting Status
POSTED
time Frame
From Day 1 to End of cycle 2 treatment (approximately 56 days)
title
Number of Participants With Grade 3 or Grade 4 (G3/4) Infusion Reactions by the End of Treatment Cycle 2
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice