NCT02944565 · OUTCOME

Infusion-related Reactions (IRR)

Daratumumab in Treating Patients With Multiple Myeloma · Source last updated 2019-09-09

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

Measure: NUMBER
Unit: participants with IRR
Interval / dispersion: Not reported
Time frame: Up to 6 months

What was measured

IRR will be assessed during the first infusion using the accelerated dosing regimen. Number of patients who develop grade 3 or above IRR utilizing the accelerated infusion will be used for safety analysis.

Groups in this outcome

Treatment (Daratumumab)

Patients received daratumumab 16 mg/kg IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.

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

Analysis denominator · Participants

Group	Source count
Treatment (Daratumumab)	28

Reported measurements

Source class 1

Values in participants with IRR · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Daratumumab)	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0

denoms

counts
group Id
OG000
value
28
units
Participants

description

groups

description
Patients received daratumumab 16 mg/kg IV over 1.5 hours. Treatment continues in the absence of disease progression or unacceptable toxicity.
id
OG000
title
Treatment (Daratumumab)

param Type

NUMBER

reporting Status

POSTED

time Frame

Up to 6 months

title

Infusion-related Reactions (IRR)

type

SECONDARY

unit Of Measure

participants with IRR

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

Preserved source evidence · Not medical advice