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NCT05511428 · OUTCOME

Number of Adverse Events During Infusion Center Administration

Home Based Daratumumab Administration for Patients With Multiple Myeloma · Source last updated 2025-11-21

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

Measure
NUMBER
Unit
adverse events
Interval / dispersion
Not reported
Time frame
Cycle 1, Cycle 2, Cycle 7, and Cycle 8, days 1-57 and 169-197

What was measured

Safety will be evaluated through collection of adverse events. Total number of adverse events that occurred more than 1% of the time during cycles 1, 2, 7, and 8 when Darzalex-Faspro was administered at the infusion center.

Analysis population: All participants who received Darzalex-Faspro during specified cycles.

Groups in this outcome

Treatment (daratumumab and hyaluronidase-fihj)

Patients receive daratumumab and hyaluronidase-fihj SC over 3-5 minutes in the infusion center on day 1 of cycles 1, 2, 7, and 8 and at home on day 1 of cycles 3, 4, 5, and 6. Cycles repeat every 28 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies

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

Analysis denominator · Participants

GroupSource count
Treatment (daratumumab and hyaluronidase-fihj)19

Reported measurements

Source class 1
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (daratumumab and hyaluronidase-fihj)82Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        82
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    units
    Participants
description
Safety will be evaluated through collection of adverse events. Total number of adverse events that occurred more than 1% of the time during cycles 1, 2, 7, and 8 when Darzalex-Faspro was administered at the infusion center.
groups
  1. description
    Patients receive daratumumab and hyaluronidase-fihj SC over 3-5 minutes in the infusion center on day 1 of cycles 1, 2, 7, and 8 and at home on day 1 of cycles 3, 4, 5, and 6. Cycles repeat every 28 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Daratumumab and Hyaluronidase-fihj: Given SC Questionnaire Administration: Ancillary studies Quality-of-Life Assessment: Ancillary studies Interview: Ancillary studies
    id
    OG000
    title
    Treatment (daratumumab and hyaluronidase-fihj)
param Type
NUMBER
population Description
All participants who received Darzalex-Faspro during specified cycles.
reporting Status
POSTED
time Frame
Cycle 1, Cycle 2, Cycle 7, and Cycle 8, days 1-57 and 169-197
title
Number of Adverse Events During Infusion Center Administration
type
SECONDARY
unit Of Measure
adverse events

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

Preserved source evidence · Not medical advice